Latest news with #Mifepristone
Yahoo
4 days ago
- General
- Yahoo
Abortion opponents are coming for mifepristone using what medical experts call ‘junk science'
Packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023, in Rockville, Maryland. (Photo illustration by) Using flawed studies and scientific journal publications, abortion opponents are building a body of research meant to question the safety of the abortion pill mifepristone, a key target for the movement. The effort comes as federal officials have expressed a willingness to revisit the drug's approval — and potentially impose new restrictions on a medication used in the vast majority of abortions. This report was originally published by The 19th. The Illuminator is a founding member of the 19th News Network. Mainstream medical researchers have criticized the studies, highlighting flaws in their methodology and — in the case of one paper published by the conservative think tank Ethics and Public Policy Center (EPPC) — lack of transparency about the data used to suggest mifepristone is unsafe. The vast body of research shows that the drugs used in medication abortion, mifepristone and misoprostol, are safe and effective in terminating a pregnancy. 'There's a proliferation of anti-abortion propaganda right now. I think it is a coordinated attack on mifepristone,' said Ushma Upadhyay, an associate professor at the University of California, San Francisco who studies medication abortion. Released in April, the EPPC paper suggests that mifepristone results in serious adverse events for 1 in 10 patients — substantially higher than the widely accepted figure of .3 percent complication rate most research has attributed to the pill. The paper appears to count what other researchers say are non-threatening events, such as requiring follow-up care to complete the abortion, or visiting an emergency room within 45 days of an abortion — even if the patient did not end up requiring emergency care — as serious adverse effects. That paper also did not go through peer review, a standard process for scientific research in which other scholars review a study's findings and methodology before it can be published. Another paper, a commentary piece published this week in the journal BioTech, challenges the commonly cited statistic that mifepristone has a lower complication rate than acetaminophen, or Tylenol, tracing the history of the comparison and arguing that it is mathematically flawed. The paper's author, Cameron Loutitt, is a biomedical engineer by training and director of life sciences at the Charlotte Lozier Institute, a research arm of the anti-abortion group SBA Pro-Life America. SUBSCRIBE: GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX 'My hope is that this paper sparks action in my peers in the research and medical community to more critically evaluate these unfounded claims regarding abortion drug safety,' Loutitt said in a statement. Days later, a group of researchers from the institute published another study, this one arguing that emergency rooms are likely to identify medication abortions as miscarriages, which they say increases the risk of needing hospital care. A miscarriage and a medication abortion are medically indistinguishable, and patients will sometimes visit an emergency room to ensure the drugs worked, or if they suspect possible complications. In places where abortion is illegal, patients may also tell health care providers they experienced a miscarriage to minimize their legal risk. Studies like the Lozier Institute paper suggest complications from medication abortions are being undercounted. That study was rejected by another journal on April 12 before being published this week, noted Upadhyay, who had served as a peer reviewer in that rejection process. A similar paper written by many of the same researchers behind the Lozier Institute's was retracted a year ago by the journal that published it, along with two others suggesting mifepristone was unsafe. 'They keep trying to publish the same junk science,' Upadhyay said. James Studnicki, the Charlotte Lozier Institute's director of data analytics, who led the second of its new anti-abortion papers and the study retracted last year, did not respond to a request for comment. But a spokesperson for the institute said the organization is challenging last year's retraction through an arbitration process. This March, Studnicki said in a statement that the retraction placed 'politics over publication ethics.' These studies and papers all fall outside the scientific consensus. More than 100 studies over decades of research have found that mifepristone — and the medication abortion regimen as a whole — has a low complication rate and is very safe to use for abortions. Papers like these aren't new, and their scientific accuracy has long been questioned. But the bevy of new reports and analyses comes at a moment when abortion opponents may have more influence in shaping public policy. Mifepristone restrictions are a top priority for the anti-abortion movement. About two-thirds of all abortions in the United States are now done using medication. Even in states with abortion bans, pregnant people have increasingly turned to abortion medication, which they receive from health providers in states with laws protecting abortion. Nationwide, about 1 in 5 abortions are now performed using telehealth; almost half of those are for people in states with bans or restrictions. Mifepristone is currently approved for use through 10 weeks of pregnancy. Health and Human Services Secretary Robert F. Kennedy Jr. testified before a Senate committee that he has directed the Food and Drug Administration to review the approval of mifepristone, citing the EPPC paper specifically. Jim O'Neill, who is nominated for a deputy secretary role, has also said he is in favor of a 'safety review' of the drug — a move that could result in new restrictions on how it is prescribed. Meanwhile, physicians and researchers are highlighting the rigor of the FDA approval process. 'FDA approval of mifepristone must reflect the rigorous clinical evidence that has proven unequivocally that it is safe and effective for use in medication,' 13 reproductive medical organizations, including the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, said in a statement after Kennedy indicated the drug may undergo a new FDA review. 'Mifepristone has been used for decades for abortion and miscarriage management by millions of patients, and complications are exceedingly rare, minor, and most often easily treatable.' The International Institute for Reproductive Loss, an anti-abortion nonprofit, has explicitly prioritized the publication of research that supports restrictions on medication abortion. Presenting at an anti-abortion conference last September, that organization's science director, Priscilla Coleman, highlighted strategies that she said could help result in the retraction of studies showing mifepristone's safety, such as finding 'agenda-driven, poorly developed and conducted studies published in peer-reviewed journals' and writing to journal editors. Coleman did not respond to a request for comment. Though no scientific consensus has changed, anti-abortion lawmakers have rallied around the suggestion that complications are common. In a private Zoom meeting reported on by Politico, abortion opponents cited the EPPC paper as a potential tool to justify further restrictions on mifepristone — even while acknowledging that the report is 'not a study in the traditional sense' and 'not conclusive proof of anything.' Sen. Josh Hawley, a Republican from Missouri, cited the EPPC paper in a letter to FDA Commissioner Marty Makary, who had only a day before the report's publication indicated openness to reviewing mifepristone's approval if new evidence emerged. 'The time to act is now. It is time to revisit and restore the FDA's longstanding safety measures governing mifepristone,' Hawley wrote. His office did not reply to a request for further comment. 'They're producing this terrible 'science' because they don't have any real science that backs them up. And all they've gotten from the administration is, 'Yeah, we'll study it,'' said David Cohen, a law professor at Drexel University who has advised state legislatures on crafting abortion-protetctive laws. Through the courts and Trump administration, abortion opponents have pushed to reverse a 2021 FDA decision allowing mifepristone to be distributed via telehealth. In addition to calling for the in-person requirement to be reinstated, abortion opponents are asking for restrictions such as the dispensation of the drug to require three in-person visits, and for mifepristone to only be approved for use only in the first seven weeks of pregnancy. Many have also argued the drug should be taken off the market entirely. The Trump administration said on the campaign trail that it would leave abortion policy up to the states. So far, there has been little indication from the federal government that such changes are imminent. 'Pills are kind of just spreading, as we predicted, without almost any restriction and so far the anti-abortion movement hasn't figured out what to do,' Cohen said. SUPPORT: YOU MAKE OUR WORK POSSIBLE This story was originally reported by Shefali Luthra of The 19th. Meet Shefali and read more of her reporting on gender, politics and policy.
Yahoo
19-05-2025
- Health
- Yahoo
Reproductive-rights groups push against Kennedy's mifepristone review
Reproductive-rights advocates are pushing back against the review of the abortion medication mifepristone ordered by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. Kennedy directed the Food and Drug Administration (FDA) to review the medication during a Senate hearing Wednesday because of findings laid out in a new study conducted by the Ethics and Public Policy Center (EPPC), a conservative think tank. Advocates say Kennedy is using inaccurate data on the drug to justify going against the existing science on mifepristone. They say the 'new data' Kennedy mentioned comes from a flawed analysis that anti-abortion groups across the country are using to persuade the Trump administration to impose restrictions on the medication or ban its use. 'It's clear they are ignoring decades of peer-reviewed research demonstrating mifepristone safety and the FDA's own review of this research,' said Ushma Upadhyay, professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco. 'The FDA could be doing even more to eliminate medically unjustified barriers to these medications. Instead, there is now an effort to use junk science as a basis for even more restrictions,' she added. Kennedy has said in the past that mifepristone should be reviewed, most notably during his Senate confirmation hearing in January when he said President Trump had asked him to study the safety of the drug. 'Patients should not be losing access to the safest and most effective regimen for care based on junk science for political wins,' said Julia Kaye, senior staff attorney with the American Civil Liberties Union's Reproductive Freedom Project. Medication abortions typically involve the use of two drugs, mifepristone and misoprostol. Mifepristone stops a pregnancy from continuing, and misoprostol is used to induce cramping and bleeding in order to empty the uterus. Mifepristone was first approved by the FDA in 2000 for the medical termination of a pregnancy up to seven weeks after conception, according to the agency's website. And the drug was approved for the termination of a pregnancy up to 10 weeks of gestation in 2016. 'Right now, mifepristone is available, but that reality is in jeopardy,' said Jen Castle, national director of abortion care and access at the Planned Parenthood Federation of America. 'A back-door effort like this undermines the FDA's credibility and puts our entire drug approval system in the balance.' The Supreme Court recently ruled to preserve access to medication abortions, but such access continues to change. There are 28 states that restrict access to abortion medication in some way, either due to total abortion bans or regulations on who can prescribe it and how patients can receive it, according to the Guttmacher Institute, an abortion and reproductive rights nonprofit. Research shows that medication abortions have a roughly 99 percent success rate when terminating a pregnancy, with a 0.4 percent risk of serious complications and a mortality rate of 0.001 percent. More than 100 scientific studies have been conducted to examine the safety and efficacy of using mifepristone and misoprostol to end a pregnancy. All of them found that both medications are safe. More than 7.5 million people have used mifepristone to end a pregnancy or to treat a miscarriage since it was first approved 25 years ago, according to Planned Parenthood. In 2023, 63 percent of all abortions in the country were performed using medication, according to data from the Guttmacher Institute. 'The safety and efficacy of mifepristone is well established. Disinformation attempts to mislead the public on the safety and efficacy of mifepristone are also not new,' said Skye Perryman, president and CEO of Democracy Forward. Perryman was also the former general counsel for the American College of Obstetricians and Gynecologists and was involved in litigation requiring the FDA to allow mifepristone to be sent to patients in the mail. 'It is alarming to see the Secretary respond to political pressure and suggest that science and evidence are evaluated at the White House, as opposed to by career experts who have studied and evaluated mifepristone for decades.' Reproductive-rights groups and scientists alike have questioned the findings and methodology of the new study Kennedy referenced during his Senate hearing earlier this week. The EPPC said the study, released last month, is an analysis of insurance claims for more than 85,000 medication abortions from 2017 to 2023 that shows almost 11 percent of women experienced a serious adverse event after ingesting the drugs, nearly 22 times higher than what the FDA reports. Upadhyay said one of the biggest flaws of the study is its inclusion of emergency room visits as one of the 'serious adverse events' that can occur after taking abortion medication. In the study, 'serious adverse events' are broken down into categories. Some of those categories include hemorrhage, sepsis, transfusion and emergency room. It appears that the trips to the emergency room were counted as an adverse event even if health care workers deemed the patient fine and released them without any treatment, according to Upadhyay. The clumping of all emergency room visits without a clear explanation for the visit and its outcome appears to be an attempt by the study's crafters to 'artificially and inaccurately' inflate the health risks associated with mifepristone, she added. The highest number of abortion complications fall under the category of 'other abortion-specific complications,' and nowhere in the study does it clearly explain what those complications are. The study also does not name the insurance claim database used, saying only that it is compiled from a 'commercially available all-payer health insurance claims database including de-identified data' purchased by the organization. A spokesperson for HHS said the FDA continues to be committed to safeguarding public health by 'ensuring the safety, efficacy, and quality of the products it regulates.' 'The agency rigorously evaluates the latest scientific data, leveraging gold standard science to make informed decisions. With a steadfast focus on protecting consumers, the FDA applies a balanced, science-based approach while incorporating practical, common-sense considerations to its regulatory processes,' HHS spokesperson Andrew Nixon wrote in an email to The Hill. An EPPC spokesperson said the group could not share the source of its data due to restrictions imposed on it by the data vendor. 'We are committed to honoring those contractual obligations,' EPPC spokesperson Hunter Estes wrote. 'However, I will note that this insurance data is available from approximately a dozen data brokers and is widely used by researchers and health professionals.' Estes referred to a recently published FAQ document about the report in response to questions on the 'serious adverse events' categories. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
19-05-2025
- Health
- The Hill
Reproductive-rights groups push against Kennedy's mifepristone review
Reproductive-rights advocates are pushing back against the review of the abortion medication mifepristone ordered by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. Kennedy directed the Food and Drug Administration (FDA) to review the medication during a Senate hearing Wednesday because of findings laid out in a new study conducted by the Ethics and Public Policy Center (EPPC), a conservative think tank. Advocates say Kennedy is using inaccurate data on the drug to justify going against the existing science on mifepristone. They say the 'new data' Kennedy mentioned comes from a flawed analysis that anti-abortion groups across the country are using to persuade the Trump administration to impose restrictions on the medication or ban its use. 'It's clear they are ignoring decades of peer-reviewed research demonstrating mifepristone safety and the FDA's own review of this research,' said Ushma Upadhyay, professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco. 'The FDA could be doing even more to eliminate medically unjustified barriers to these medications. Instead, there is now an effort to use junk science as a basis for even more restrictions,' she added. Kennedy has said in the past that mifepristone should be reviewed, most notably during his Senate confirmation hearing in January when he said President Trump had asked him to study the safety of the drug. 'Patients should not be losing access to the safest and most effective regimen for care based on junk science for political wins,' said Julia Kaye, senior staff attorney with the American Civil Liberties Union's Reproductive Freedom Project. Medication abortions typically involve the use of two drugs, mifepristone and misoprostol. Mifepristone stops a pregnancy from continuing, and misoprostol is used to induce cramping and bleeding in order to empty the uterus. Mifepristone was first approved by the FDA in 2000 for the medical termination of a pregnancy up to seven weeks after conception, according to the agency's website. And the drug was approved for the termination of a pregnancy up to 10 weeks of gestation in 2016. 'Right now, mifepristone is available, but that reality is in jeopardy,' said Jen Castle, national director of abortion care and access at the Planned Parenthood Federation of America. 'A back-door effort like this undermines the FDA's credibility and puts our entire drug approval system in the balance.' The Supreme Court recently ruled to preserve access to medication abortions, but such access continues to change. There are 28 states that restrict access to abortion medication in some way, either due to total abortion bans or regulations on who can prescribe it and how patients can receive it, according to the Guttmacher Institute, an abortion and reproductive rights nonprofit. Research shows that medication abortions have a roughly 99 percent success rate when terminating a pregnancy, with a 0.4 percent risk of serious complications and a mortality rate of 0.001 percent. More than 100 scientific studies have been conducted to examine the safety and efficacy of using mifepristone and misoprostol to end a pregnancy. All of them found that both medications are safe. More than 7.5 million people have used mifepristone to end a pregnancy or to treat a miscarriage since it was first approved 25 years ago, according to Planned Parenthood. In 2023, 63 percent of all abortions in the country were performed using medication, according to data from the Guttmacher Institute. 'The safety and efficacy of mifepristone is well established. Disinformation attempts to mislead the public on the safety and efficacy of mifepristone are also not new,' said Skye Perryman, president and CEO of Democracy Forward. Perryman was also the former general counsel for the American College of Obstetricians and Gynecologists and was involved in litigation requiring the FDA to allow mifepristone to be sent to patients in the mail. 'It is alarming to see the Secretary respond to political pressure and suggest that science and evidence are evaluated at the White House, as opposed to by career experts who have studied and evaluated mifepristone for decades.' Reproductive-rights groups and scientists alike have questioned the findings and methodology of the new study Kennedy referenced during his Senate hearing earlier this week. The EPPC said the study, released last month, is an analysis of insurance claims for more than 85,000 medication abortions from 2017 to 2023 that shows almost 11 percent of women experienced a serious adverse event after ingesting the drugs, nearly 22 times higher than what the FDA reports. Upadhyay said one of the biggest flaws of the study is its inclusion of emergency room visits as one of the 'serious adverse events' that can occur after taking abortion medication. In the study, 'serious adverse events' are broken down into categories. Some of those categories include hemorrhage, sepsis, transfusion and emergency room. It appears that the trips to the emergency room were counted as an adverse event even if health care workers deemed the patient fine and released them without any treatment, according to Upadhyay. The clumping of all emergency room visits without a clear explanation for the visit and its outcome appears to be an attempt by the study's crafters to 'artificially and inaccurately' inflate the health risks associated with mifepristone, she added. The highest number of abortion complications fall under the category of 'other abortion-specific complications,' and nowhere in the study does it clearly explain what those complications are. The study also does not name the insurance claim database used, saying only that it is compiled from a 'commercially available all-payer health insurance claims database including de-identified data' purchased by the organization. A spokesperson for HHS said the FDA continues to be committed to safeguarding public health by 'ensuring the safety, efficacy, and quality of the products it regulates.' 'The agency rigorously evaluates the latest scientific data, leveraging gold standard science to make informed decisions. With a steadfast focus on protecting consumers, the FDA applies a balanced, science-based approach while incorporating practical, common-sense considerations to its regulatory processes,' HHS spokesperson Andrew Nixon wrote in an email to The Hill. An EPPC spokesperson said the group could not share the source of its data due to restrictions imposed on it by the data vendor. 'We are committed to honoring those contractual obligations,' EPPC spokesperson Hunter Estes wrote. 'However, I will note that this insurance data is available from approximately a dozen data brokers and is widely used by researchers and health professionals.' Estes referred to a recently published FAQ document about the report in response to questions on the 'serious adverse events' categories.
Yahoo
15-05-2025
- Business
- Yahoo
Cushing's Disease Market Poised for Significant Growth Across the 7MM During the Study Period (2020-2034) with Rising Awareness and Diagnostic Improvements
The Cushing's disease pipeline possesses some drugs in mid and late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including relacorilant, clofutriben, atumelnant, and others. The expected launch of these therapies shall further create a positive impact on the Cushing's disease market. LAS VEGAS, May 15, 2025 /PRNewswire/ -- DelveInsight's Cushing's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Cushing's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Cushing's Disease Market Report According to DelveInsight's analysis, the market size for Cushing's disease was found to be USD 1 billion in the 7MM in 2024. In 2024, among all the current therapies for Cushing's disease, the highest revenue was generated by Mifepristone (KORLYM and generics) in the US. Based on DelveInsight's assessment in 2024, the 7MM had approximately 37K diagnosed prevalent cases of Cushing's disease. These cases are expected to rise due to advancements in diagnostic capabilities and increased awareness about the disease during the forecast period (2025–2034). Leading Cushing's disease companies developing emerging therapies, such as Corcept Therapeutics, Sparrow Pharmaceuticals, Crinetics Pharmaceuticals, H. Lundbeck, Stero Therapeutics, and others, are developing novel Cushing's disease drugs that can be available in the Cushing's disease market in the coming years. The promising Cushing's disease therapies in the pipeline include DUPIXENT (dupilumab), Linerixibat (GSK2330672), NEMLUVIO/MITCHGA (nemolizumab), Volixibat, and others. In March 2025, Corcept Therapeutics announced that the FDA had assigned a PDUFA target action date of December 30, 2025, for relacorilant to treat patients with endogenous hypercortisolism. In February 2025, Crinetics Pharmaceuticals mentioned that the company anticipates beginning enrollment for Atumelnant (CRN04894) in Phase Ib/IIa trials for Cushing's disease in late 2025 or early 2026. In October 2024, Sparrow Pharmaceuticals announced that clofutriben had been granted Orphan Drug Designation (ODD) by the US FDA for the treatment of endogenous Cushing's syndrome. Discover which therapies are expected to grab the major Cushing's disease market share @ Cushing's Disease Market Report Cushing's Disease Overview Cushing's disease is a rare but serious endocrine disorder caused by a pituitary tumor that triggers excessive cortisol production. It presents with a variety of symptoms such as weight gain, fatigue, mood disturbances, high blood pressure, and impaired glucose tolerance. Cushing's syndrome is responsible for 80–85% of hypercortisolism cases, with 75–80% of those linked to ACTH-producing pituitary adenomas. Without treatment, the 5-year survival rate is only about 50%, emphasizing the urgent need for effective therapies. Diagnosing Cushing's disease is especially difficult because it is rare, shares symptoms with other disorders, and presents in various ways. Only 40–60% of patients have a detectable tumor on standard Magnetic Resonance Imaging (MRI), and the diagnosis is often delayed by an average of 7 years. Cushing's Disease Epidemiology Segmentation The Cushing's disease epidemiology section provides insights into the historical and current Cushing's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Cushing's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Cushing's Disease Total Diagnosed Prevalent Cases of Cushing's Disease Gender-Specific Diagnosed Prevalent Cases of Cushing's Disease Age-Specific Diagnosed Prevalent Cases of Cushing's Disease Cushing's Disease Treatment Market The primary treatment for Cushing's disease is usually transsphenoidal surgery to remove the pituitary tumor, which often leads to remission. However, some patients may experience a recurrence. When surgery is unsuccessful or not an option, medical therapies are used to control cortisol levels. Various medications are available for managing Cushing's disease, especially in cases where surgery is ineffective or not feasible. One such drug is KORLYM, developed by Corcept Therapeutics, approved for treating hyperglycemia in patients with Cushing's syndrome who also have Type 2 diabetes or glucose intolerance. In 2024, a generic version by Teva Pharmaceuticals entered the market, adding competition, and Corcept itself has released a generic version as well. Other approved options include SIGNIFOR and SIGNIFOR LAR, ISTURISA, and RECORLEV. In addition, off-label drugs like ketoconazole, metyrapone, cabergoline, mitotane, and etomidate are also used in the U.S., with some marketed in Europe by HRA Pharma. SIGNIFOR (pasireotide), developed by Recordati, was the first drug specifically approved for Cushing's disease by the FDA in 2012, and also gained EU approval. Recordati also markets SIGNIFOR LAR, a long-acting injectable version approved by the FDA and Japan's PMDA in 2018. This formulation, administered intramuscularly once every four weeks, shares the same mechanism as SIGNIFOR but offers a different delivery route. Recordati is recognized as a leading player in this therapeutic area. Another key product from the company is ISTURISA (osilodrostat), the first FDA-approved oral drug that inhibits cortisol production by targeting the enzyme 11β-hydroxylase (CYP11B1), which is involved in the final step of cortisol synthesis. Its oral administration makes it more convenient for patients compared to injectable therapies. ISTURISA is also being studied for pediatric use in an ongoing Phase II trial (NCT03708900). RECORLEV, originally developed by Strongbridge Biopharma and later acquired by Xeris Pharmaceuticals, was approved by the FDA in 2021. It is indicated for adults with endogenous Cushing's syndrome who are not surgical candidates or did not achieve a cure through surgery. Unlike ISTURISA, RECORLEV works by inhibiting cortisol production at multiple points in the steroidogenesis pathway, offering a distinct mechanism of action. To know more about Cushing's disease treatment guidelines, visit @ Cushing's Disease Management Cushing's Disease Pipeline Therapies and Key Companies Relacorilant (CORT125134): Corcept Therapeutics Clofutriben (SPI-62): Sparrow Pharmaceuticals Atumelnant (CRN04894): Crinetics Pharmaceuticals Lu AG13909: H. Lundbeck ST-002: Stero Therapeutics Discover more about Cushing's disease drugs in development @ Cushing's Disease Clinical Trials Cushing's Disease Market Dynamics The Cushing's disease market dynamics are expected to change in the coming years. Although Cushing's disease is generally considered a rare condition, growing awareness and recent advances in research suggest that diagnoses may rise in the future; despite a seemingly crowded market, many current hypercortisolism treatments fail to normalize cortisol levels effectively and pose significant side effects highlighting a substantial opportunity for innovation, especially given the limited therapies specifically targeting Cushing's disease and the potential of newer oral alternatives like ISTURISA and RECORLEV to offer greater flexibility compared to SC and intramuscular options such as SIGNIFOR and SIGNIFOR LAR. Furthermore, potential therapies are being investigated for the treatment of Cushing's disease, and it is safe to predict that the treatment space will significantly impact the Cushing's disease market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Cushing's disease market in the 7MM. However, several factors may impede the growth of the Cushing's disease market. Due to non-specific guidelines and recommendations, patients with Cushing's disease often face suboptimal care, delayed diagnosis, and inconsistent treatment approaches, further compounded by the diagnostic complexity, frequent misdiagnosis, and symptom overlap with more common conditions, which leave many undiagnosed or untreated; while existing therapies such as ketoconazole and metyrapone approved in Europe based on limited retrospective data and used off-label in the US despite high costs are widely trusted and entrenched in clinical practice, posing a significant barrier to the adoption of emerging therapies. Moreover, Cushing's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Cushing's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Cushing's disease market growth. Cushing's Disease Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [The United States, the EU4 (Germany, France, Italy, and Spain) and The United Kingdom, and Japan]. Cushing's Disease Market Size in 2024 USD 1 Billion Key Cushing's Disease Companies Xeris Pharmaceuticals, Recordati, Corcept Therapeutics, Sparrow Pharmaceuticals, H. Lundbeck, Stero Therapeutics, Crinetics Pharmaceuticals, and others Key Cushing's Disease Therapies RECORLEV, ISTURISA, SIGNIFOR, SIGNIFOR LAR, KORLYM, Relacorilant, Clofutriben, Lu AG13909, ST-002, Atumelnant, and others Scope of the Cushing's Disease Market Report Therapeutic Assessment: Cushing's Disease current marketed and emerging therapies Cushing's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Cushing's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Cushing's Disease Market Access and Reimbursement Download the report to understand which factors are driving Cushing's disease market trends @ Cushing's Disease Market Trends Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary 4 Key Events 5 Epidemiology and Market Forecast Methodology 6 Cushing's Disease Market Overview at a Glance 6.1 Market Share (%) Distribution by Therapies of Cushing's Disease in 2024 6.2 Market Share (%) Distribution by Therapies of Cushing's Disease in 2034 7 Disease Background and Overview 7.1 Introduction 7.2 Clinical and Biological Characteristics 7.3 Genetics of Cushing's Disease 7.4 Pathogenesis and Pathophysiology 7.5 Complications of Cushing's Disease 7.6 Diagnosis of Cushing's Disease 7.6.1 Diagnostic Algorithm 7.7 Treatment and Management of Cushing's Disease 7.7.1 Treatment Algorithm of Cushing's Disease 8 Guidelines, Recommendations, and Management for Cushing's Disease 8.1 Consensus on Diagnosis and Management of Cushing's Disease: A Guideline Update (2020) (The United States) 8.2 Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline (2015) (Europe) 8.3 Clinical Significance of Screening for Subclinical Cushing's Disease in Patients With Pituitary Tumors (2010) (Japan) 9 Epidemiology and Patient Population 9.1 Key Findings 9.2 Assumptions and Rationales 9.3 Total Diagnosed Prevalent Cases of Cushing's Disease in the 7MM 9.4 The United States 9.4.1 Total Diagnosed Prevalent Cases of Cushing's Disease in the US 9.4.2 Gender-specific Diagnosed Prevalent Cases of Cushing's Disease in the US 9.4.3 Age-specific Diagnosed Prevalent Cases of Cushing's Disease in the US 9.5 EU4 and the UK 9.5.1 Total Diagnosed Prevalent Cases of Cushing's Disease in EU4 and the UK 9.5.2 Gender-specific Diagnosed Prevalent Cases of Cushing's Disease in EU4 and the UK 9.5.3 Age-specific Diagnosed Prevalent Cases of Cushing's Disease in EU4 and the UK 9.6 Japan 9.6.1 Total Diagnosed Prevalent Cases of Cushing's Disease in Japan 9.6.2 Gender-specific Diagnosed Prevalent Cases of Cushing's Disease in Japan 9.6.3 Age-specific Diagnosed Prevalent Cases of Cushing's Disease in Japan 10 Patient Journey 11 Marketed Drug 11.1 Marketed Drug Details 11.2 ISTURISA (osilodrostat): Recordati 11.2.1 Product Description 11.2.2 Regulatory Milestones 11.2.3 Other Developmental Activities 11.2.4 Clinical Development Activities 11.2.4.1 Clinical Trials Information 11.2.5 Safety and Efficacy 11.3 RECORLEV (levoketoconazole): Xeris Pharmaceuticals 11.3.1 Product Description 11.3.2 Regulatory Milestones 11.3.3 Other Developmental Activities 11.3.4 Safety and Efficacy 11.4 SIGNIFOR (pasireotide): Recordati 11.4.1 Product Description 11.4.2 Regulatory Milestones 11.4.3 Other Developmental Activities 11.4.4 Safety and Efficacy 11.5 SIGNIFOR LAR (pasireotide pamoate): Recordati 11.5.1 Product Description 11.5.2 Regulatory Milestones 11.5.3 Other Developmental Activities 11.5.4 Safety and Efficacy 12 Emerging Drugs 12.1 Key Cross Competition 12.2 Relacorilant (CORT125134): Corcept Therapeutics 12.2.1 Product Description 12.2.2 Other Development Activity 12.2.3 Clinical Development 12.2.3.1 Clinical Trial Information 12.2.4 Safety and Efficacy 12.3 Clofutriben (SPI-62): Sparrow Pharmaceuticals 12.3.1 Product Description 12.3.2 Other Development Activity 12.3.3 Clinical Development 12.3.3.1 Clinical Trial Information 12.3.4 Safety and Efficacy 12.4 Atumelnant (CRN04894): Crinetics Pharmaceuticals 12.4.1 Product Description 12.4.2 Other Development Activity 12.4.3 Clinical Development 12.4.3.1 Clinical Trial Information 12.4.4 Safety and Efficacy 13 Cushing's Disease: Seven Major Market Analysis 13.1 Key Findings 13.2 Market Outlook 13.3 Key Market Forecast Assumptions 13.3.1 Cost Assumptions and Rebates 13.3.2 Pricing Trends 13.3.3 Analogue Assessment 13.3.4 Launch Year and Therapy Uptakes 13.4 Conjoint Analysis 13.5 Total Market Size of Cushing's Disease in the 7MM 13.6 Market Size of Cushing's Disease by Therapies in 7MM 13.7 The United States 13.7.1 Total Market Size of Cushing's Disease in the US 13.7.2 Market Size of Cushing's Disease by Therapies in the US 13.8 EU4 and the UK 13.8.1 Total Market Size of Cushing's Disease in the EU4 and the UK 13.8.2 Market Size of Cushing's Disease by Therapies in EU4 and the UK 13.9 Japan 13.9.1 Total Market Size of Cushing's Disease in Japan 13.9.2 The Market Size of Cushing's Disease by Therapies in Japan 14 Unmet Needs 15 SWOT Analysis 16 KOL Views 17 Market Access and Reimbursement 17.1 The United States 17.1.1 Centre for Medicare and Medicaid Services (CMS) 17.2 EU4 and the UK 17.2.1 Germany 17.2.2 France 17.2.3 Italy 17.2.4 Spain 17.2.5 United Kingdom 17.3 Japan 17.3.1 MHLW 17.4 Market Access and Reimbursement of Cushing's Disease 18 Appendix 18.1 Bibliography 18.2 Report Methodology 19 DelveInsight Capabilities 20 Disclaimer 21 About DelveInsight Related Reports Cushing's Syndrome Market Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. Cushing's Syndrome Pipeline Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Cushing's syndrome companies, including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. Endogenous Cushing's Syndrome Market Endogenous Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endogenous Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others. Endogenous Cushing's Syndrome Pipeline Endogenous Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endogenous Cushing's syndrome companies, including Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ + Logo: View original content: SOURCE DelveInsight Business Research, LLP
New York Post
15-05-2025
- Health
- New York Post
HHS chief RFK Jr. says he's ordered a ‘complete review' of chemical abortion pill
Health and Human Services Secretary Robert F. Kennedy Jr. revealed Wednesday that he has ordered the Food and Drug Administration (FDA) to conduct a 'complete review' of a chemical abortion pill amid reports that the drug isn't as safe as advertised. 'It's alarming,' RFK Jr. said of a recent study conducted by the Ethics & Public Policy Center that found nearly 11% of women who used the popular abortion pill mifepristone experienced a 'serious adverse event.' 'I have asked Marty Makary, who is the director at FDA, to do a complete review and report back,' the HHS secretary revealed during a Senate Health, Labor, Education and Pensions Committee hearing. 3 The FDA will conduct a 'complete review' of mifepristone after reports that the drug isn't as safe as advertised. REUTERS The Ethics & Public Policy Center study – the 'largest-known' on the abortion pill – analyzed insurance claims data from 865,727 prescribed mifepristone abortions between 2017 and 2023. The study found 10.93% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion. Sen. Josh Hawley (R-Mo.) cited the group's research as he questioned RFK Jr. during the hearing and noted that the study showed the rate of serious adverse health effects 'is 22 times higher than the FDA's current label' for mifepristone, 'which says it's just 0.5%.' 'Clearly [the study] indicates, at the very least, that the label should be changed,' Kennedy Jr. told Hawley. Mifepristone was originally approved by the FDA in 2000. 3 Health and Human Services Secretary Robert F. Kennedy Jr. ordered the FDA to review mifepristone after reports of safety concerns. Jack Gruber-USA TODAY via Imagn Images 3 Demonstrators rallied in support of abortion rights at the US Supreme Court in Washington, DC, on April 15, 2023. AFP via Getty Images The Ethics & Public Policy Center, which released its findings last month, argued that the FDA should implement 'stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects,' in light of its study. 'The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether,' the group concluded. The FDA initially OK'd mifepristone for chemical abortions up to seven weeks into a pregnancy — a timeframe that was later extended to 10 weeks under former President Barack Obama. Former President Joe Biden opened the door to FDA approval of mifepristone prescriptions online or through the mail, which the Supreme Court upheld in a unanimous ruling last year. The Washington, DC-based Ethics and Public Policy Center is a conservative think tank and advocacy group that seeks 'to apply the riches of the Jewish and Christian traditions to contemporary questions of law, culture, and politics, in pursuit of America's continued civic and cultural renewal,' according to the group's website.
