FDA Approves Gilead Sciences’ Sunlenca
Sunlenca, a Gilead Sciences therapy for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, has received FDA approval for the second time of asking. Sunlenca, which is based on the HIV capsid inhibitor lenacapavir, is intended to be used in addition to current HIV treatment. In trials, 81% of participants on the regimen achieved HIV RNA suppression, meaning their HIV levels were low enough to be considered undetectable after 6 months, with 83% showing continued viral load suppression after a year.
The drug was rejected by the US regulator earlier this year, just a few months after t...