The US Food and Drug Administration on Monday approved a low-cost version of a twice-yearly HIV prevention shot, bringing the breakthrough drug closer to market in low-income countries.\n<\/p>\n
The tentative approval was announced by the Indian maker of the generic version of lenacapavir, Dr. Reddy\u2019s Laboratories,\u00a0 and by Unitaid, a global health initiative.\n<\/p>\n
The generic will be available for $40 per person per year in 120 countries, under a pricing agreement announced in September 2025 between Unitaid, the African health research institute Wits RHI, and the Clinton Health Access Initiative and Dr. Reddy\u2019s.\n<\/p>\n
Lenacapavir was first developed by US pharmaceutical company Gilead Sciences and approved in June 2025 after proving more than 99.9 per cent effective in large clinical trials.<\/p>\n
\u201cThis is an extraordinary milestone for global health. For too long, people in lower- and middle-income countries have had to wait a decade or more to access breakthrough medicines already available elsewhere,\u201d Unitaid\u2019s senior strategy lead for HIV and pandemic preparedness, Carmen Perez-Casas, told AFP.\n<\/p>\n
\u201cWith lenacapavir, we\u2019ve reduced that gap to little more than a year. Having an FDA-approved generic at $40 per person per year \u2014 a price comparable to daily HIV prevention pills \u2014 is a remarkable achievement.\u201d<\/p>\n
A twice-yearly injectable that is akin to a vaccine \u2014 albeit without training the immune system \u2014 can be a more effective way to administer HIV pre-exposure prophylaxis than daily pills, which first won US approval in 2012 but only work if taken consistently.<\/p>\n
But lenacapavir\u2019s high cost \u2014 roughly $28,000 per year in the US, though insurance lowers what patients pay \u2014 was a major obstacle to its becoming a game-changer against a disease that has killed over 40 million people in four decades.\n<\/p>\n
In late 2024, Gilead granted voluntary licences for lenacapavir to six generic manufacturers, including Dr. Reddy\u2019s.\n<\/p>\n
Even before generic availability, more than 125,000 people in 10 early adopter African countries have already started Gilead\u2019s lenacapavir, Unitaid\u2019s statement said.\n<\/p>\n
\u201cThis is a moment of immense pride for all of us at Dr. Reddy\u2019s,\u201d said Deepak Sapra, CEO of Pharmaceutical Services and API at Dr. Reddy\u2019s, in a statement.\n<\/p>\n
The generic was granted \u201ctentative approval\u201d by the FDA, Unitaid said, under an accelerated pathway that allows sponsors to use existing data.\n<\/p>\n
\u2013 From approval to rollout \u2013\n<\/p>\n
Lenacapavir was named \u201cBreakthrough of the Year\u201d in 2024 by the prestigious journal Science, which hailed the basic research underpinning the drug, specifically a new understanding of HIV\u2019s capsid protein, which forms a protective shell around the virus\u2019s genetic material and which lenacapavir targets.<\/p>\n
An HIV infection once condemned patients to Acquired Immunodeficiency Syndrome (AIDS), when the immune system is so damaged that everyday germs make people very sick.\n<\/p>\n
The first antiretrovirals that could fully suppress HIV and stave off AIDS were developed in 1996, with current generations even better, allowing people to live normal life spans while managing their chronic infection.\n<\/p>\n
Oral PrEP pills came along in 2012, and before lenacapavir, a PrEP drug called cabotegravir was approved in 2021, requiring shots every two months.\n<\/p>\n
Perez-Casas said the real work for lenacapavir was still ahead, in moving from approval to rollout.\n<\/p>\n
\u201cAn estimated 1.2 million people acquired HIV last year, even as we now have a medicine offering near-100 per cent protection with just two injections a year,\u201d she said.\n<\/p>\n
\u201cThe demand is high, and we cannot afford to lose momentum. Unitaid is already working with governments and partners to support country-led rollouts, ensuring that communities play a central role in bringing this breakthrough to the people who need it most.\u201d\n<\/p>\n
AFP<\/p>\n","protected":false},"excerpt":{"rendered":"The US Food and Drug Administration on Monday approved a low-cost version of a twice-yearly HIV prevention shot,…\n","protected":false},"author":2,"featured_media":664942,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":["post-664941","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-il","tag-israel","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/664941","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=664941"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/664941\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/664942"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=664941"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=664941"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=664941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}