During market trading hours on Wednesday, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences, Inc.’s GILD Yeztugo (lenacapavir) 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 U.S. for people who need or want PrEP.
Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative.
The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012.
Also Read: Gilead’s HIV Prevention Drug Could Be Manufactured At Shocking Low Cost: Report
In the PURPOSE 1 trial, 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, 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.
In both trials, Yeztugo, the company’s injectable HIV-1 capsid inhibitor, also demonstrated superiority in the prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified.
In the U.S., Gilead is working closely with insurers, healthcare systems and other payers to ensure 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 has submitted a marketing authorization application (MAA) and EU-Medicines for all (EU-M4all) applications with the European Medicines Agency (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.
Pricing
Citing an email from a Gilead spokesperson, CNBC noted that Yeztugo’s annual list price in the U.S. before insurance is $28,218.
A month’s supply of Truvada and Descovy, Gilead’s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year.
One dose of GSK Plc’s GSK Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance.
Winnie Byanyima, Executive Director of UNAIDS and United Nations Undersecretary-General, said, “Lenacapavir could be the tool we need to bring new infections under control, but only if it is priced affordably and made available to everyone who could benefit.”
“UNAIDS has seen research that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of rollout. It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing…,” Byanyima added.
AIDS Healthcare Foundation President Michael Weinstein sharply criticized Gilead’s outrageous pricing, saying, “What could be an extraordinary game changer for HIV prevention is being completely undermined by Gilead’s greed. Charging $28,218 a year will drastically limit the availability of the drug. Gilead continues to feast on tens of billions of dollars, much of which is public funding for their HIV portfolio, at the expense of people living with or at risk of acquiring HIV.”
Price Action: GILD stock is trading higher by 1.16% to $109.25 premarket at last check Friday.
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