HIV Prevention Shot: FDA Approval News
Long-Lasting HIV Prevention Shot poised for FDA Approval
Updated June 7, 2025
A new twice-yearly injection to prevent HIV, lenacapavir, is on track for potential FDA approval later this month. The drug, developed by Gilead Sciences, could considerably advance HIV pre-exposure prophylaxis (PrEP) efforts.
Gilead Sciences’ study involving women and girls demonstrated the shot’s effectiveness, with no participants contracting HIV. This success has boosted Gilead’s stock, according to the Wall Street Journal.
“We no it’s challenging to take a daily pill for prevention, and we see an amazing opportunity here,” said Johanna Mercier, Gilead’s chief commercial officer.
Currently, over 400,000 people in the U.S. use daily pills for HIV prevention, but Gilead anticipates this number could exceed 1 million within the next decade. A survey indicated that 95% of current PrEP users would opt for a long-acting injection.
Other long-acting options, such as GSK’s Apretude, have seen sales increase, rising 63% in the past year.
Despite promising results, challenges remain. Black Americans, who account for 39% of new HIV cases, represent only 14% of current PrEP users. Stigma and lack of insurance coverage can limit access.
Gilead emphasizes its commitment to reaching underserved communities, noting that Medicaid will be crucial for expanding access to lower-income individuals. Some experts are concerned that the new shot might replace existing Gilead products like Descovy.Though, Gilead believes the injection will expand PrEP usage both domestically and internationally.
“we’re thinking globally about the public health impact we can have,” Mercier stated.
The company is collaborating with governments and health organizations in the U.K.and other countries to increase awareness and availability of these products.
What’s next
The FDA’s decision on lenacapavir is expected soon, possibly offering a new, more convenient option for HIV prevention and expanding access to PrEP for those who need it most.