"Gilead Sciences’ Yeztugo receives nod; the first and only US FDA-approved HIV prevention option offering 6 months of protection
Foster City-headquartered Gilead Sciences Inc, a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, announced that the US FDA has approved Yeztugo (lenacapavir) - the company’s injectable HIV-1 capsid inhibitor - as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP.
• “This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, chairman and CEO of Gilead Sciences.
• “This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the US FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”
• Yeztugo by Gilead is the first and only FDA-approved HIV prevention shot offering 6 months of protection.
• Gilead also developed the first PrEP (pre-exposure prophylaxis) medication, approved in 2012.
• Despite medical advances, only 36% of eligible individuals in the US were prescribed a form of PrEP in 2022 (CDC data).
• Key gaps in PrEP uptake exist among:
Women
Black/African American & Hispanic/Latino populations
Southern US communities
• Barriers to PrEP usage include:
Poor awareness among healthcare providers and patients
Adherence challenges
• In 2023, over 100 new HIV diagnoses occurred daily in the US, highlighting the urgent need for better access, awareness, and acceptance of PrEP solutions like Yeztugo.
• “Yeztugo could be the transformative PrEP option we’ve been waiting for - offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Carlos del Rio, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research in Atlanta.
• “A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.”
• US FDA approval of Yeztugo is supported by high efficacy and demonstrated safety data in two clinical trials. Data show that =99.9% of participants who received Yeztugo in the phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative.
• The US FDA approval of Gilead’s NDAs for Yeztugo was supported by data from the phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead.
• In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed 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 (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa.
• In the PURPOSE 2 trial (NCT04925752), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group, demonstrating 99.9% of participants in the Yeztugo group did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.
• In both trials, 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.
• Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 “Breakthrough of the Year.”
• Yeztugo received US FDA approval under priority review.
• Additionally, in October 2024, Yeztugo was granted Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy.
Gilead’s US access strategy for Yeztugo is designed to enable broad uptake and availability for individuals with and without insurance coverage.
• In the US, Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo.
• Additionally, for eligible commercially insured individuals with commercial insurance, Gilead’s Advancing Access Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars.
Gilead outside US
• Outside of the US, Gilead is executing an access strategy, informed by global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review, approval of and access to twice-yearly lenacapavir for PrEP.
• Gilead has submitted a marketing authorization application and EU-medicines for all (EU-M4all) application with the EMA, both of which the EMA has validated and will review under an accelerated assessment timeline.
• Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada and South Africa. Additionally, now that Yeztugo has received US FDA approval, Gilead is preparing additional filings in countries that rely on US FDA approval for regulatory submission, including Argentina, Mexico and Peru.
• Gilead will continue to share updates on additional regulatory filings.
Lenacapavir approval
• Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.
• Lenacapavir 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.
• The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents.
• While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.
• Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program.
• Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV.
• The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”
Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.
• Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection.
• Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection.
• Do not initiate Yeztugo unless negative infection status is confirmed.
• Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen.
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