Latest news with #Omvoh
Yahoo
28-05-2025
- Business
- Yahoo
Eli Lilly vs. AstraZeneca: Which Pharma Powerhouse is the Better Buy?
Eli Lilly LLY and AstraZeneca AZN are leading drugmakers with significant involvement in oncology, immunology, and the cardiometabolic disease space. Both are making substantial investments in next-generation therapies such as cancer immunotherapies, treatments for respiratory conditions as well as GLP-1 drugs. With robust, research-driven pipelines and strong growth potential, they represent an intriguing comparison for investors considering large-cap pharmaceutical stocks. Though both companies have a diversified product profile, Lilly's largest segment is Cardiometabolic Health, which accounts for 72% of its total revenues. Lilly has a strong portfolio of medicines to treat diabetes and other cardiometabolic diseases. Its cardiometabolic business is its most successful business, particularly with the success of its popular GLP-1 drugs, Mounjaro for diabetes and Zepbound for obesity. On the other hand, Oncology is AstraZeneca's biggest segment, comprising around 41% of its total revenues. The company is working on strengthening its oncology product portfolio through label expansions of existing products and advancement of oncology pipeline candidates. Both Lilly and AstraZeneca are seeing strong sales and earnings growth. But which one is a better investment today? Let's take a closer look at their fundamentals, growth prospects and challenges to make an informed choice. Lilly boasts a wide range of products that serve a vast number of therapeutic areas. The company focuses primarily on cardiometabolic health, neuroscience, oncology and immunology, which are all high-growth areas with significant commercial potential. Despite being on the market for less than three years, Mounjaro and Zepbound became key top-line drivers for Lilly, with demand rising rapidly. Mounjaro and Zepbound generated combined sales of $6.15 billion in the first quarter of 2025, accounting for around 48% of the company's total revenues. Though sales of Mounjaro and Zepbound were below expectations in the second half of 2024, hurt by slower-than-expected growth and unfavorable channel dynamics, their sales picked up in the first quarter of 2025, driven by launches of the drugs in new international markets and improved supply from ramped-up production. We believe that increased uptake in outside U.S. markets and deeper penetration in the U.S. market will continue to drive Mounjaro and Zepbound's growth in future quarters. Approvals for new indications can also drive sales of Mounjaro and Zepbound higher. Other than Mounjaro and Zepbound, Lilly has gained approvals for some other new drugs in the past couple of years across different therapeutic areas like Omvoh, Jaypirca, Ebglyss and Kisunla (donanemab). Lilly expects its new drugs, Mounjaro, Zepbound, Omvoh, Jaypirca, Ebglyss and Kisunla, along with the expanded use of existing drugs, to drive sales growth in 2025. Lilly is also making rapid pipeline progress in obesity, diabetes and cancer, with several key mid and late-stage data-readouts expected this year. Lilly is investing broadly in obesity and has several new molecules currently in clinical development. In terms of capital allocation, LLY returned $2.5 billion to shareholders in the first quarter via share repurchases and dividends. The board of directors of Lilly approved a new $15 billion stock buyback plan and also announced a 15% increase in its quarterly dividend in 2024. Lilly has its share of problems. Sales of its key medicine, Trulicity, are declining in the United States due to competitive dynamics, including Mounjaro switches and supply constraints. Prices of most of Lilly's products are declining in the United States. Potential competition in the GLP-1 diabetes/obesity market is another headwind. The stock also took a hit this month because CVS Caremark, a major pharmacy benefit manager ('PBM'), announced a partnership with rival Novo Nordisk NVO to make NVO's Wegovy its preferred GLP-1 therapy for weight loss, effective July 1. NVO also recently announced partnerships with telehealth providers Hims & Hers Health to offer Wegovy at a discounted price to cash-paying patients. Though Lilly's CEO, Dave Ricks does not expect CVS' decision to exclude Zepbound in favor of Wegovy to hurt Lilly's revenues, we believe it may hurt Zepbound's market share. Headquartered in Cambridge, the United Kingdom, AstraZeneca boasts a diversified geographical footprint as well as a product portfolio with several blockbuster medicines. AstraZeneca now has 16 blockbuster medicines in its portfolio with sales exceeding $1 billion, including Tagrisso, Fasenra, Farxiga, Imfinzi, Lynparza, Calquence and Ultomiris. These drugs are driving the company's top line, backed by increasing demand trends. The company is confident that the growth will continue in 2025. Almost every new product it has launched in recent years has done well. Newer drugs like Wainua, Airsupra, Saphnelo, Datroway (partnered with Daiichi Sankyo) and Truqap are also expected to continue to contribute to top-line growth in 2025. Backed by its new products and pipeline drugs, AstraZeneca believes it can post industry-leading top-line growth in the 2025-2030 period. AstraZeneca expects to generate $80 billion in total revenues by 2030, a significant increase from the $54 billion it generated in 2024. By the said time frame, AstraZeneca plans to launch 20 new medicines, with nine new medicines already launched/approved. It believes that many of these new medicines will have the potential to generate more than $5 billion in peak-year revenues. The company is also on track to achieve a mid-30s percentage core operating margin by 2026. AstraZeneca faces its share of challenges. The impact of Part D redesign hurt sales of AZN's older drugs, Tagrisso, Lynparza and Ultomiris, as well as newer drugs, Truqap and Wainua, in the United States in the first quarter of 2025, with the trend expected to continue through the rest of the year. AstraZeneca expects Farxiga and Lynparza to be included in the volume-based procurement plans in China in mid-2025, which can hurt sales of these drugs in the country. Pricing and competitive pressure in Europe and generic competition in some emerging markets are expected to hurt drug sales. In 2025, generic/biosimilar competition in the United States is expected to hurt sales of key drugs like Brilinta and Soliris. Sales in its Rare Disease segment are expected to be slower in 2025 than in 2024. As regards shareholders' returns, AstraZeneca intends to increase its annual dividend per share to $3.20 per share in 2025. The Zacks Consensus Estimate for LLY's 2025 sales and EPS implies a year-over-year increase of 32.6% and 70.0%, respectively. EPS estimates for 2025 as well as 2026 have declined over the past 60 days. Image Source: Zacks Investment Research The Zacks Consensus Estimate for AstraZeneca's 2025 sales and EPS implies a year-over-year increase of 6.7% and 9.3%, respectively. EPS estimates for both 2025 and 2026 have risen over the past 60 days. Image Source: Zacks Investment Research Year to date, while LLY's stock has declined 5.7%, AstraZeneca's stock has risen 9.8%. The industry has declined 4.5% in the said time frame. Image Source: Zacks Investment Research Both Lilly and AZN are priced higher than the industry from a valuation standpoint. Lilly is more expensive than AstraZeneca, going by the price/earnings ratio. Lilly's shares currently trade at 28.31 forward earnings, higher than 15.13 for AZN. However, both AZN and LLY are trading at discounts to their 5-year mean. Image Source: Zacks Investment Research Lilly's dividend yield is 0.8%, while AZN's is much higher at around 2.9%. Image Source: Zacks Investment Research Lilly's return on equity of 85.5% is higher than AZN's 33.1%. Both Lilly and AstraZeneca have a Zacks Rank #3 (Hold), which makes choosing one stock a difficult task. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Lilly is a good stock to have in one's portfolio, considering its diversified product and pipeline portfolio and robust growth prospects despite its expensive valuation. Lilly's tremendous success with Mounjaro and Zepbound has made it the largest drugmaker with a market cap of more than $650 billion. In 2025, Lilly expects to record revenues in the range of $58.0 billion to $61.0 billion, indicating an impressive 32% year-over-year growth. However, considering Lilly's several near-term challenges, AstraZeneca looks like a safer bet for short-term investors, given its price appreciation, cheaper valuation and robust growth prospects. Despite the potential impact from Part D redesign, AstraZeneca expects total revenues to grow by a high single-digit percentage at CER in 2025. AstraZeneca expects core EPS to increase by a low double-digit percentage. Consistently rising estimates also indicate analysts' optimistic outlook for growth. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Medical News Today
24-05-2025
- Health
- Medical News Today
Omvoh side effects: Common, mild, and serious
As with other drugs, Omvoh (mirikizumab-mrkz) can cause side effects, such as herpes viral infection. If you are not able to tolerate side effects of Omvoh, talk with your doctor or pharmacist. Omvoh (mirikizumab-mrkz) is a brand-name drug that's prescribed for adults to treat moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. 'Active' means the condition is currently causing symptoms. The side effects you experience may vary depending on the condition being treated. If you have problems with side effects from Omvoh, talk with your doctor or pharmacist. They can discuss ways to manage side effects or other available treatment options. Do not stop Omvoh treatment without consulting your doctor first. Omvoh can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects persist, bother you, or become severe, be sure to talk with your doctor or pharmacist. The following are just a few of the more common side effects reported by people who took Omvoh in studies. These side effects can vary depending on the condition being treated. More common side effects in people taking Omvoh for Crohn's disease include: upper respiratory infection, such as a sinus infection injection site reactions elevated liver enzyme tests headache joint pain For more information about some of these side effects, see the 'Side effect specifics' section. Mild side effects can occur with Omvoh use. This list does not include all possible mild side effects of the drug. For more information, you can refer to Omvoh's prescribing information. Mild side effects that have been reported with Omvoh include: upper respiratory infection, such as a sinus infection injection site reactions elevated liver enzyme tests headache joint pain skin rash or hives herpes viral infection These side effects may be temporary, lasting a few days to weeks. However, if the side effects continue, worsen, or become too difficult to tolerate, be sure to talk with your doctor or pharmacist. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect during treatment with Omvoh and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088. For more information about some of these side effects, see the 'Side effect specifics' section. Omvoh may cause serious side effects. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Omvoh's prescribing information. If you develop serious side effects during Omvoh treatment, call your doctor right away. If the side effects seem life threatening or you think you're having a medical emergency, immediately call 911 or your local emergency number. Serious side effects that have been reported and their symptoms include: increased risk of serious infections, such as pneumonia; symptoms will vary based on the specific infection but may include: fever, chills, and sweating cough fatigue liver problems Allergic reaction For some people, Omvoh can cause an allergic reaction. In general, symptoms of allergic reaction can be mild or serious. Ways to manage For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They'll also let you know whether you should continue taking the medication. For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you've had a serious allergic reaction to a drug, your doctor may recommend taking a different medication instead. Learn more about some of the side effects that Omvoh may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Omvoh. Herpes viral infection was a rare side effect reported in studies of Omvoh for treating ulcerative colitis. This side effect was not reported in studies where Omvoh was used to treat Crohn's disease. It's important to note that Omvoh doesn't 'give' you herpes. Treatment with Omvoh can raise your risk of any infection, including infections caused by the herpes virus. And if you've already been exposed to the herpes simplex virus, treatment with Omvoh could trigger an outbreak that causes symptoms to appear. Herpes zoster (shingles) may cause symptoms such as: a skin rash that's similar to chickenpox but appears in only certain areas, such as on your waist, chest, back, or abdomen, and typically affects one side of your body fluid-filled blisters that are part of the rash a constant burning, dull, or gnawing pain or an on-and-off sharp, stabbing pain Oral herpes simplex may cause symptoms including cold sores (also called fever blisters) that develop in or around your mouth or lips. In rare cases, the sores can also appear on your tongue, your face, or other areas of your skin. If you've previously been exposed to the herpes virus, treatment with Omvoh could cause a symptom outbreak. If you have symptoms of a herpes infection while taking Omvoh, talk with your doctor. They'll likely recommend treatment with an antiviral drug such as acyclovir or valacyclovir (Valtrex). They may also recommend other treatments for managing symptoms, which will vary based on your specific symptoms and the type of infection. Liver problems were a very rare side effect in studies of Omvoh. Symptoms of this side effect include: elevated liver enzymes, which your doctor may notice on a liver function test yellowing of your skin or the whites of your eyes abdominal pain If you have an existing liver condition, such as cirrhosis, you may be at higher risk of developing this side effect from Omvoh treatment. For at least the first 24 weeks of treatment, your doctor will order blood tests to check your liver function. Based on the results of these tests, your doctor may temporarily or permanently stop your Omvoh treatment. If you notice symptoms of liver damage while taking Omvoh, let your doctor know right away. Your doctor may temporarily or permanently stop your Omvoh treatment. In studies, liver function tests returned to normal after stopping Omvoh. Injection site reactions were commonly reported in studies of Omvoh. These are side effects that appear at or around the site where Omvoh is injected. Injection site reactions reported with Omvoh include: pain skin redness or discoloration hives In most cases, Omvoh injection site reactions are temporary and go away on their own in a few hours or days. But if you have symptoms that bother you or don't go away, talk with your doctor. They can recommend ways to relieve your symptoms. Omvoh may cause several side effects. Here are some frequently asked questions about the drug's side effects and their answers. Possibly. Omvoh treatment begins with three doses given by intravenous (IV) infusion. In studies of Omvoh, infusion-related reactions included itchiness, skin redness or discoloration, and anaphylaxis. These side effects occur during or shortly after the infusion. While similar side effects can happen with subcutaneous injections of Omvoh, it's not clear whether anaphylaxis occurred after subcutaneous injections in studies. During Omvoh infusions, a healthcare professional will be available to immediately treat any infusion reaction that develops. Talk with your doctor if you have additional questions about what you might expect from Omvoh infusions. Possibly, but it isn't clear whether long-term side effects happened in studies of Omvoh. For example, liver problems, including liver injury, are rare but did happen in these studies. However, liver function appears to return to normal once Omvoh is stopped. Omvoh can raise your risk of infections, including tuberculosis (TB). In rare cases, certain infections can cause long-term complications. Omvoh's prescribing information doesn't detail whether any long-term infections occurred. Your doctor or pharmacist can answer questions you may have about Omvoh treatment and your risk of long-term side effects. Before starting treatment with Omvoh, discuss your health history with your doctor. Omvoh may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you: active infection latent tuberculosis (TB) liver condition, such as cirrhosis recent or upcoming vaccinations previous allergic reaction to this or a similar drug pregnancy breastfeeding alcohol consumption Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. Ulcerative Colitis Pharmacy / Pharmacist Drugs Medical News Today has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical journals and associations. We only use quality, credible sources to ensure content accuracy and integrity. You can learn more about how we ensure our content is accurate and current by reading our editorial policy.
Yahoo
21-03-2025
- Business
- Yahoo
J&J's Tremfya Gets FDA Nod for 2nd IBD Condition Crohn's Disease
Johnson & Johnson JNJ announced that the FDA has granted approval to its key drug, Tremfya, for its second inflammatory bowel disease (IBD) condition — moderately to severely active Crohn's disease ('CD'). For the CD indication, Tremfya has gained approval for both subcutaneous ('SC') and intravenous ('IV') induction options. The approval for the CD indication was based on data from the phase III GALAXI and GRAVITI studies, which demonstrated the robust efficacy of SC or IV Tremfya in achieving clinical and endoscopic endpoints. So far this year, J&J's shares have risen 12.7% compared with the industry's 7.0% increase. Image Source: Zacks Investment Research Tremfya was approved for its first IBD condition, moderately to severely active ulcerative colitis ('UC'), in September 2024. Tremfya, an IL-23 inhibitor, is already approved to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU. Crohn's disease marks the fourth indication for Tremfya in the United States. Tremfya is under review in the EU for both UC and CD indications. Tremfya is an important drug in J&J's immunology drug portfolio and a key driver of top-line growth. The drug generated sales of $3.67 billion in 2024, up 16.6% year over year, driven by strong market growth and share gains. The approval of Tremfya for the IBD conditions, UC and CD is the key to its growth. J&J expects Tremfya to be a $5 billion product with approvals in IBD conditions. In recent years, there has been a surge in the prevalence of gastrointestinal disorders like UC and CD due to genetic factors, environmental factors and lifestyle changes. In addition, immune system irregularities, higher diagnosis rates, increased focus on early diagnosis and favorable reimbursement policies in developed countries are driving demand for IBD treatments. Several big drugmakers are developing new medicines with novel mechanisms of action to help patients with UC and CD achieve long-term clinical remission. Some other key players in the IBD market are AbbVie ABBV, Eli Lilly LLY, Pfizer, Novartis, Merck MRK, Sanofi, Gilead and Amgen. Some of these companies have also in-licensed rights to IBD candidates with improved clinical profiles from smaller drugmakers in the past two to three years. AbbVie has been seeing strong performance of its key immunology drugs, Skyrizi and Rinvoq, in IBD indications. In 2024, AbbVie acquired smaller biotechs like Landos Biopharma and Celsius Therapeutics, which are making novel drugs for treating IBD. It also signed a license agreement with China's FutureGen to develop a next-generation anti-TL1A antibody for IBD. Lilly's Omvoh was approved for UC in the United States, Europe and Japan in 2023. Omvoh was approved for CD in the United States in January 2025, while applications are under review in Europe and Japan. In 2024, Lilly acquired small biotech Morphic Therapeutics, whose lead pipeline candidate is MORF-057, in mid-stage development for both UC and CD. In 2023, Merck acquired small biotech Prometheus Biosciences, which added tulisokibart to its pipeline. Tulisokibart, a novel TL1A inhibitor, is being developed in phase III for UC. In 2023, Roche acquired Telavant, including rights to the novel TL1A-directed antibody (RVT-3101) from Roivant for the treatment of IBD conditions. In October 2023, Sanofiin-licensed rights to jointly develop and commercialize Teva Pharmaceutical's IBD candidate, duvakitug/TEV-48574, an anti-TL1A therapy. Duvakitug is being evaluated in a phase IIb study for UC and CD, with a phase III study expected to begin this year. J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Johnson & Johnson price-consensus-chart | Johnson & Johnson Quote Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Johnson & Johnson (JNJ) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Associated Press
31-01-2025
- Health
- Associated Press
FDA Approval of Eli Lilly's Omvoh for Crohn's Disease Adds a New Option, but Uptake May be Hampered by US Gastroenterologists' Brand Preferences Among the IL-23 Class, According to Spherix Global Insights
EXTON, PA, Jan. 31, 2025 (GLOBE NEWSWIRE) -- The FDA's approval of Eli Lilly's Omvoh for Crohn's disease marks a significant milestone as the therapy becomes the second IL-23 inhibitor available for patients with this challenging condition. Omvoh, already approved for ulcerative colitis, now sets its sights on carving out a niche in the Crohn's disease market. Yet, stiff competition from AbbVie's Skyrizi and an expected approval for Johnson & Johnson's Tremfya raises questions about Omvoh's ability to stand out in Crohn's. Spherix Global Insights recently completed the Q4 2024 wave of its RealTime Dynamix™: Crohn's Disease (US) service, engaging with 101 U.S.-based gastroenterologists to evaluate the evolving Crohn's treatment landscape. Findings from this research highlight that while Omvoh enjoys greater familiarity among physicians compared to Tremfya, it faces hurdles in key pre-launch metrics. Nearly half of gastroenterologists view Tremfya as a significant advancement over existing options, compared to just one-third who believe the same for Omvoh. Moreover, over half indicate Tremfya as their preferred IL-23 inhibitor in development for Crohn's disease, while only 20% selected Omvoh. Despite these challenges, Omvoh sits within a class that is gaining momentum, with almost half of respondents citing IL-23s as the best overall mechanism of action for Crohn's treatment. Although TNF inhibitors including adalimumab and infliximab remain the mainstay for first-line biologic treatment in Crohn's, use of Skyrizi has grown steadily since it was approved, carving out share from the TNFs and Johnson & Johnson's Stelara. One gastroenterologist from the Spherix study who chose Omvoh as the preferred treatment in development note that the '[The] drug seems to have the right MOA to reduce inflammation and promote remission.' For Omvoh to grow alongside its fellow IL-23s, the product will need to carve out its own unique value proposition. Omvoh's initial indication in ulcerative colitis represented Lilly's first foray into the IBD space, and the brand has grown in share slowly but steadily since launch while facing competition from manufacturers with deep roots in gastroenterology. In ulcerative colitis, Omvoh focused on addressing bowel urgency – a critical patient concern. Gastroenterologists recognize addressing urgency is equally important in Crohn's disease, with more than two-thirds agreeing that it is an important treatment goal. A gastroenterologist in the Spherix study who indicated preference for Omvoh among treatments in development noted that it can provide 'Lasting remission and improved bowel urgency.' Spherix will closely monitor Omvoh's impact on the Crohn's disease market through its RealTime Dynamix™ service. In addition, Spherix will track Omvoh's performance during the first 18 months post-launch via the Launch Dynamix™ service, slated to begin in February 2025. With the IL-23 class continuing to gain traction, the coming months will reveal whether Omvoh can establish a unique foothold amid fierce competition. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit LinkedIn. NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorse.
