FDA Approves Twice-Yearly HIV Injection | Becker’s Hospital Review
The FDA has approved lenacapavir,a groundbreaking twice-yearly injectable for HIV prevention. This decision marks a significant advancement, offering a new, long-acting option for at-risk adults and adolescents. Clinical trials confirmed lenacapavir’s exceptional efficacy, with over 99.9% of participants remaining HIV-negative. Gilead Sciences will offer affordable access, including low-cost or no-cost options for the uninsured. This innovative approach could dramatically improve adherence too HIV prevention strategies. News Directory 3 is closely following this development. Now that this new option is available, what’s the next step in the fight against HIV? discover what’s next …
FDA Approves Injectable Lenacapavir for HIV Prevention Role
Updated June 19, 2025
The food and Drug Administration has given the green light to lenacapavir, manufactured by Gilead Sciences, as a preventative measure against HIV. This marks the first injectable medication, administered just twice per year, approved for at-risk adults and adolescents seeking HIV prevention.
The FDAS decision hinged on Phase 3 trial results.Data indicated that more than 99.9% of participants receiving the lenacapavir injection remained HIV negative, according to a news release from Gilead on June 18. This new option for HIV prevention offers a long-acting choice to daily oral medications.
Public health officials and researchers anticipate that this long-lasting injectable will improve both access to and adherence to HIV prevention strategies. the twice-yearly injection schedule contrasts sharply with daily oral regimens.
Gilead sciences is working to ensure insurance coverage for lenacapavir. the company also stated the drug will be available at little to no cost for uninsured individuals in the U.S. Applications for approval have been submitted in other countries, the company said.