Will the FDA approve Lenacapavir as PrEP by the end of 2025?
Yes • 50%
No • 50%
FDA official announcements and press releases
Lenacapavir Reduces HIV Infection Risk to Nearly 0% in Phase 3 Trial, Injectable Every Six Months
Dec 8, 2024, 03:45 PM
Lenacapavir, a novel pre-exposure prophylaxis (PrEP), has shown promising results in reducing the risk of HIV infection to nearly 0% in a phase 3 trial involving adolescent girls and young women in South Africa and Uganda. Unlike traditional vaccines, lenacapavir is an antiretroviral drug that inhibits HIV replication rather than training the immune system to recognize the virus. It is administered just under the skin every six months. Additionally, another injectable PrEP, cabotegravir, is available, requiring an injection every two months. Both options provide new avenues for HIV prevention, highlighting the evolving landscape of antiretroviral therapies.
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Approved in EU only • 25%
Approved in both USA and EU • 25%
Not approved in USA or EU • 25%
Approved in USA only • 25%
No • 50%
Yes • 50%
Both countries • 25%
Neither country • 25%
South Africa • 25%
Uganda • 25%
Asia • 25%
North America • 25%
South America • 25%
Europe • 25%