generic long-acting lenacapavir approved by FDA for HIV prevention; $40pp/year!

[from Carlyn Amole, CHAI]

The injection from our partner Dr. Reddy’s costs just $40 per person per year in 120 low- and middle-income countries after our landmark pricing agreement last year. First supplies should reach countries before the end of this year.

Generic HIV medicines used to trail the originator approval by a decade or more. We did it in just over a year. Read more at our press release:

https://www.clintonhealthaccess.org/news/us-fda-approves-first-generic-injectable-lenacapavir-for-hiv-prevention/

Huge congratulations to the CHAI team and to our incredible partners at Unitaid, Wits RHI, and Dr. Reddy’s. Now we’re focused on getting lenacapavir to the millions of people who need it around the world.

[AP News]

Approval of a cheap version of HIV-prevention shot lenacapavir raises hopes in low-income countries

The U.S. Food and Drug Administration has approved a generic version of the world’s only twice-a-year shot to prevent HIV — a big step toward making the drug available inexpensively and more quickly in 120 low- and middle-income countries.

The announcement was made on Monday morning by the manufacturer and organizations that helped to speed up development of the medication, called lenacapavir. …

Until now, Gilead has been the sole supplier of lenacapavir, and demand has outstripped supply in low- and middle-income countries. Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to enable production. Those voluntary licenses cover a specific set of countries in sub-Saharan Africa, Asia and Latin America. …

The generic was developed by India-based Dr. Reddy’s Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative and Wits RHI, a health research institute in Africa. The partners sought to accelerate development and make the drug available at an affordable price. …

Generic lenacapavir should start to become available in some places within weeks, those helping with the effort said, although it could take a bit longer in countries that require the drug to go through their own approval processes before people can start taking it. Generic versions made by the other manufacturers have yet to be approved by FDA.

Source: LinkedIn https://lnkd.in/p/ebXVE3s5