FDA Approves Twice-Yearly Injectable for HIV Prevention
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By Alice Thompson | WASHINGTON – 2025/06/18 22:58:17
The Food and Drug Governance (FDA) has given the green light to Gilead Sciences’ lenacapavir, a first-of-its-kind, twice-yearly injectable medication designed to prevent HIV in at-risk adults and adolescents.
According to a press release issued by the drugmaker on June 18, the FDA’s decision was influenced by data from a Phase 3 trial.The trial demonstrated that over 99.9% of participants who received the lenacapavir injection remained HIV negative.
This new injectable stands in contrast to daily oral medications currently used for HIV protection. Public health officials and researchers anticipate that this long-acting option will enhance both access to and adherence to HIV prevention strategies.
Gilead has stated that they are actively working to ensure insurance coverage for the drug. Furthermore, they aim to make it available at little to no cost for uninsured individuals in the U.S. The company has also submitted applications seeking approval in other countries.
“More than 99.9% of participants who received the injection remained HIV negative.”
Frequently Asked questions
- What is lenacapavir?
- Lenacapavir is a twice-yearly injectable medication approved by the FDA for HIV prevention in at-risk adults and adolescents.
- How effective is lenacapavir?
- Clinical trials showed that over 99.9% of participants receiving lenacapavir remained HIV negative.
- How often is the injection administered?
- the injection is administered twice a year.
- Will lenacapavir be affordable?
- Gilead is working to ensure insurance coverage and will offer the drug at low or no cost for uninsured individuals in the U.S.
