Gilead wins U.S. approval for twice yearly HIV med lenacapavir
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Gilead Sciences (NASDAQ:GILD) announced Thursday that the FDA approved its HIV capsid inhibitor, Sunlenca, in combination with other antiretrovirals for the treatment of adults with multi-drug resistant (MDR) HIV-1 infection.
With the approval, the treatment, also known as lenacapavir, becomes a new twice-yearly therapeutic option for adults with HIV-1 whose infection has not been adequately controlled by prior regimens.

The decision is backed by data from the company's Phase 2/3 CAPELLA study, which indicated an undetectable viral load at Week 52 in 83% of trial participants who received Sunlenca randomly in addition to other treatments.
"â¦.. lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who otherwise have limited therapy choices," said Sorana Segal-Maurer, Professor of Clinical Medicine at Weill Cornell Medicine and an investigator for the CAPELLA study.

In August, Gilead (GILD) announced the EU approval of Sunlenca for multi-drug resistant HIV.