The FDA has approved Gilead Sciences’ lenacapavir, a twice-yearly injectable medication to prevent HIV, making it the first drug approved for adults and adolescents who are at risk.
The FDA’s approval is based on data from a Phase 3 trial that showed that more than 99.9% of participants who received the injection remained HIV negative, according to a June 18 news release from the drugmaker.
Unlike daily oral medications used for HIV protection, this injection is administered only twice a year, with researchers and public health officials hoping the long-lasting option can improve access and adherence to HIV prevention.
Gilead said it is working to ensure the drug is covered by insurance and added that it will be available at low or no cost for people without insurance in the U.S. The company has submitted applications for approval in other countries, the release said.
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