Latest news with #GileadSciences
Globe and Mail
10 hours ago
- Health
- Globe and Mail
FDA Approves Gilead's Twice-Yearly Shot for HIV Prevention
Gilead Sciences, Inc. GILD obtained FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV. The regulatory body approved lenacapavir, under the brand name Yeztugo, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States. The FDA nod, granted under Priority Review, was based on extraordinary data from the late-stage studies, PURPOSE 1 and PURPOSE 2, which showed that ≥99.9% of participants who received Yeztugo remained HIV-negative. Year to date, shares of GILD have gained 18.6% against the industry 's decline of 4%. More on GILD's Yeztugo The approval of Yeztugo for HIV prevention is a major breakthrough in the fight against HIV epidemic. At present, there are two FDA-approved daily oral medications for PrEP — Truvada and Descovy. Both of these are marketed by GILD alone. Please note that Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. Truvada is a two-drug combination of emtricitabine and tenofovir disoproxil fumarate, approved for the treatment of HIV-1 infection and PrEP. Data from PURPOSE 1 study showed that twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada in cisgender women in sub-Saharan Africa. Data from the PURPOSE 2 study showed that 99.9% of participants in the Yeztugo group did not acquire HIV infection. Yeztugo was also superiority in preventing of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Yeztugo was also granted Breakthrough Therapy Designation in October 2024. The European Medicines Agency has also validated the Marketing Authorization Application for twice-yearly lenacapavir for HIV prevention. Yeztugo Approval – A Significant Boost for GILD As the first long-acting injectable PrEP administered just twice a year, Yeztugo addresses persistent barriers that have limited broader PrEP adoption, such as challenges with daily oral PrEP, adherence, stigma and healthcare access. This approval represents a paradigm shift in HIV prevention and is expected to catalyze uptake among populations that have historically been underserved by existing prevention tools. Yeztugo has a competitive advantage as it needs to be taken only twice yearly, unlike daily oral pills, and addresses a broad population. Gilead has a market-leading portfolio of HIV treatments. Flagship drug Biktarvy accounts for over 51% share of the treatment market in the United States and should maintain momentum. The approval of Yeztugon solidifies its HIV portfolio as its other prevention drug, Truvada, faces generic competition. We note that lenacapavir is already approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. It is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, who are at risk of HIV acquisition. A long-acting injectable form of PrEP was also approved by the FDA. In 2021, the regulatory body approved ViiV Healthcare's Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV. ViiV Healthcare is a global specialist HIV company, majorly owned by GSK plc GSK, with Pfizer and Shionogi as shareholders. The company was formed by GSK and Pfizer in 2009. Apretude is given first as two initiation injections, administered a month apart and then every two months. Patients in need can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to understand how well they can tolerate the drug. Approval of better HIV treatments should strengthen GILD's HIV franchise in the wake of increasing competition from the likes of GSK. GSK's HIV portfolio sales are being driven by strong patient demand for Cabenuva, Apretude and Dovato. The company is also focused on the development of the next generation of HIV innovation with integrase inhibitors (INSTIs) for HIV treatment and prevention. GILD's Zacks Rank and Stocks to Consider Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Novartis NVS and Bayer BAYRY, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.53 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 23 cents to $9.02 during this timeframe. The stock has risen 22% so far this year. BAYRY's 2025 EPS estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 59.8%. 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Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Novartis AG (NVS): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report
Fox News
16 hours ago
- Health
- Fox News
FDA approves first twice-yearly injection that prevents HIV infection
The U.S. Food and Drug Administration (FDA) approved a new, twice-yearly shot — the first and only of its kind — to prevent HIV, the creator of the drug, Gilead Sciences, announced on Wednesday. Sold under the name Yeztugo, the company's injectable HIV-1 capsid inhibitor (lenacapavir) reduces the risk of sexually acquired HIV in adults and adolescents. "This is a historic day in the decades-long fight against HIV," said Daniel O'Day, chairman and CEO of California-based Gilead Sciences, in a press release. The medicine, which only needs to be administered twice a year, has shown "remarkable outcomes in clinical studies," as Gilead claims it could transform HIV prevention. The drug is given as an injectable under the skin that the body then slowly absorbs. Individuals must have a negative HIV-1 test prior to starting the treatment. In large trials last year, the drug was not only nearly 100% effective in its prevention of HIV, but proved superior to once-daily oral medication like Truvada, another drug by Gilead. The journal Science named lenacapavir its 2024 "Breakthrough of the Year." Lenacapavir uses a multi-stage approach that distinguishes it from other approved antiviral medications. "While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle," states the press release from Gilead. For more Health articles, visit "Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," O'Day said in the press release. The most commonly reported adverse reactions during clinical trials included injection site reactions, headache and nausea, according to the company.
Global News
16 hours ago
- Health
- Global News
The U.S. OKs twice-a-year HIV prevention shot. Could it end transmission?
The U.S. has approved the world's only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – although it's unclear how many in the U.S. and abroad will get access to the powerful new option. While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take. 'This really has the possibility of ending HIV transmission,' said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research. Condoms help guard against HIV infection if used properly but what's called PrEP — regularly using preventive medicines such as the daily pills or a different shot given every two months — is increasingly important. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills. Story continues below advertisement But upheaval in U.S. healthcare — including cuts to public health agencies and Medicaid — and slashing of American foreign aid to fight HIV are clouding the prospects. Millett said 'gaping holes in the system' in the U.S. and globally 'are going to make it difficult for us to make sure we not only get lenacapavir into people's bodies but make sure they come back' twice a year to keep up their protection. How does the shot work? Gilead's drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It's given as two injections under the skin of the abdomen, leaving a small 'depot' of medication to slowly absorb into the body. People must test negative for HIV before getting their twice-a-year dose, Gilead warned. It only prevents HIV transmission — it doesn't block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain. Story continues below advertisement Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide. Get weekly health news Receive the latest medical news and health information delivered to you every Sunday. Sign up for weekly health newsletter Sign Up By providing your email address, you have read and agree to Global News' Terms and Conditions and Privacy Policy Only about 400,000 Americans already use some form of PrEP, a fraction of those estimated to benefit. A recent study found states with high use of PrEP saw a decrease in HIV infections, while rates continued rising elsewhere. 2:02 Doctors, health experts call on Nova Scotia to cover birth control and HIV-prevention drug About half of new infections are in women, who often need protection they can use without a partner's knowledge or consent. One rigorous study in South Africa and Uganda compared more than 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills. There were no HIV infections in those receiving the shot while about 2% in the comparison group caught HIV from infected sex partners. A second study found the twice-yearly shot nearly as effective in gay men and gender-nonconforming people in the U.S. and in several other countries hard-hit by HIV. Story continues below advertisement Ian Haddock of Houston had tried PrEP off and on since 2015 but he jumped at the chance to participate in the lenacapavir study and continues with the twice-yearly shots as part of the research follow-up. 'Now I forget that I'm on PrEP because I don't have to carry around a pill bottle,' said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities. 'Men, women, gay, straight – it really just kinds of expands the opportunity for prevention,' he added. Just remembering a clinic visit every six months 'is a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you're taking your pill every day.' Shot could 'change nothing' if unaffordable Gilead said the U.S. list price, meaning before insurance, is US$28,218 a year, which it called similar to some other PrEP options. The company said it anticipated insurance coverage but also has some financial assistance programs. Story continues below advertisement Most private insurers are supposed to cover PrEP options without a co-pay although the Supreme Court is considering a case that could overturn that requirement. Congress also is considering huge cuts to Medicaid. And while community health centers still are an option, the Trump administration has largely dismantled HIV prevention work at the Centers for Disease Control and Prevention that would normally get the message to vulnerable populations who'd qualify for the shot, said Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute. Schmid worries the shot won't meet its potential because 'we're basically pulling the rug out of HIV prevention and testing and outreach programs.' Gilead also has applications pending for the twice-yearly shot in other countries. Last fall, the company signed agreements with six generic drug makers to produce low-cost versions of the shot for 120 poor countries mostly in Africa, Southeast Asia and the Caribbean. Gilead plans to make enough shots to supply 2 million people in those countries, at no profit, until the generics are available, said company senior vice president Dr. Jared Baeten. Winnie Byanyima, executive director of UNAIDS, said in a statement the price is still too high. If it's unaffordable, she said, 'it will change nothing.' And HIV experts worry the arrangements Gilead has made to reduce costs in some countries leave out middle-income countries like some in Latin America. 'Everyone in every country who's at risk of HIV needs access to PrEP,' said Dr. Gordon Crofoot of Houston, who helped lead the study in men. 'We need to get easier access to PrEP that's highly effective like this is.'
Chicago Tribune
17 hours ago
- Health
- Chicago Tribune
The world's only twice-a-year shot to prevent HIV could stop transmission — if people can get it
The U.S. has approved the world's only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – although it's unclear how many in the U.S. and abroad will get access to the powerful new option. While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take. 'This really has the possibility of ending HIV transmission,' said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research. Condoms help guard against HIV infection if used properly but what's called PrEP — regularly using preventive medicines such as the daily pills or a different shot given every two months — is increasingly important. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills. But upheaval in U.S. healthcare — including cuts to public health agencies and Medicaid — and slashing of American foreign aid to fight HIV are clouding the prospects. Millett said 'gaping holes in the system' in the U.S. and globally 'are going to make it difficult for us to make sure we not only get lenacapavir into people's bodies but make sure they come back' twice a year to keep up their protection. Gilead's drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It's given as two injections under the skin of the abdomen, leaving a small 'depot' of medication to slowly absorb into the body. People must test negative for HIV before getting their twice-a-year dose, Gilead warned. It only prevents HIV transmission — it doesn't block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain. Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide. Only about 400,000 Americans already use some form of PrEP, a fraction of those estimated to benefit. A recent study found states with high use of PrEP saw a decrease in HIV infections, while rates continued rising elsewhere. About half of new infections are in women, who often need protection they can use without a partner's knowledge or consent. One rigorous study in South Africa and Uganda compared more than 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills. There were no HIV infections in those receiving the shot while about 2% in the comparison group caught HIV from infected sex partners. A second study found the twice-yearly shot nearly as effective in gay men and gender-nonconforming people in the U.S. and in several other countries hard-hit by HIV. Ian Haddock of Houston had tried PrEP off and on since 2015 but he jumped at the chance to participate in the lenacapavir study and continues with the twice-yearly shots as part of the research follow-up. 'Now I forget that I'm on PrEP because I don't have to carry around a pill bottle,' said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities. 'Men, women, gay, straight – it really just kinds of expands the opportunity for prevention,' he added. Just remembering a clinic visit every six months 'is a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you're taking your pill every day.' Gilead said the U.S. list price, meaning before insurance, is $28,218 a year, which it called similar to some other PrEP options. The company said it anticipated insurance coverage but also has some financial assistance programs. Most private insurers are supposed to cover PrEP options without a co-pay although the Supreme Court is considering a case that could overturn that requirement. Congress also is considering huge cuts to Medicaid. And while community health centers still are an option, the Trump administration has largely dismantled HIV prevention work at the Centers for Disease Control and Prevention that would normally get the message to vulnerable populations who'd qualify for the shot, said Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute. Schmid worries the shot won't meet its potential because 'we're basically pulling the rug out of HIV prevention and testing and outreach programs.' Gilead also has applications pending for the twice-yearly shot in other countries. Last fall, the company signed agreements with six generic drug makers to produce low-cost versions of the shot for 120 poor countries mostly in Africa, Southeast Asia and the Caribbean. Gilead plans to make enough shots to supply 2 million people in those countries, at no profit, until the generics are available, said company senior vice president Dr. Jared Baeten. Winnie Byanyima, executive director of UNAIDS, said in a statement the price is still too high. If it's unaffordable, she said, 'it will change nothing.' And HIV experts worry the arrangements Gilead has made to reduce costs in some countries leave out middle-income countries like some in Latin America. 'Everyone in every country who's at risk of HIV needs access to PrEP,' said Dr. Gordon Crofoot of Houston, who helped lead the study in men. 'We need to get easier access to PrEP that's highly effective like this is.'
Time of India
17 hours ago
- Health
- Time of India
US FDA approves Gilead's twice-yearly injection for HIV prevention
By Deena Beasley and Julie Steenhuysen Los Angeles: The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences lenacapavir , a twice-yearly injection, for preventing HIV infection in adults and adolescents at high risk of contracting the deadly virus. Investors and AIDS activists had been eagerly awaiting the regulatory decision for the drug seen as convenient enough to help end the 44-year-old HIV epidemic. It will be sold under the brand name Yeztugo in the U.S. at a list price of $28,218 a year. Lenacapavir, part of a class of drugs known as capsid inhibitors, proved nearly 100% effective at preventing HIV in large trials last year, raising new hope of interrupting transmission of the virus that infects 1.3 million people a year. Yeztugo "will only be as effective as it is accessible and affordable," Kevin Robert Frost, CEO of the Foundation for AIDS Research, said in a statement, calling on Gilead and the U.S. government to make sure people who want lenacapavir can get it. Gilead said it is working to secure health insurer coverage. It said it will provide co-pay assistance for eligible insured people, and the drug may be available free of charge for some under its program for the uninsured. Medications to prevent HIV, known as pre-exposure prophylaxis, or PrEP, are widely available. But most are daily pills, including low-cost generic versions of Gilead's older drug Truvada, that require strict adherence to be effective. Gilead said Yeztugo is priced in line with other branded drugs. "This is a milestone moment," said Gilead Chief Executive Daniel O'Day of the approval. "We believe that lenacapavir is the most important tool we have yet to bend the arc of the epidemic and move this epidemic into the history books," O'Day said. Availability of a twice-yearly HIV prevention tool is "a huge advance," that could help change the course of the epidemic, Dr. Raphael Landovitz, director of the UCLA Center for Clinical AIDS Research & Education, said in an email. But he said the product's high launch price "is almost certainly going to complicate payor coverage and access." Gilead has plans for a rapid launch in the United States as well as a wider rollout of the drug in collaboration with global partners. Gilead's chief commercial officer, Johanna Mercier, said the company's "end game" is to normalize PrEP usage, both in the United States and other countries, including low-income African nations where the virus is most prevalent. Citi Research analyst Geoff Meacham said he expects Yeztugo's launch to be slow and steady, reaching annual sales of $2.8 billion by 2030. Mercier said she expects around 75% of U.S. insurers, including government health plans, will cover lenacapavir for PrEP within about six months, with the number rising to 90% within 12 months of launch. The drug is currently sold as a treatment in the U.S. under the brand name Sunlenca for patients with advanced disease that has become resistant to other drugs. PEPFAR CUTS In December, the President's Emergency Plan for AIDS Relief (PEPFAR) under then-President Joe Biden signed an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to provide the treatment to as many as 2 million people for three years if it won U.S. regulatory approval for prevention. That would allow for unprecedented early access to a state-of-the-art treatment, as six generic drugmakers that have licensed the product from Gilead gear up for production of low-cost versions in 120 resource-limited countries. AIDS activists have viewed the drug as a way to significantly slow the epidemic, but cuts to PEPFAR by the Trump administration have raised concerns about the U.S. government's commitment to the rollout. O'Day acknowledged that the changes have been "challenging," but said the company has continued to have discussions with both the Global Fund and PEPFAR. "I believe that there will be sources of funding for this, and that these organizations will prioritize this type of prevention," he said.
