Gilead Sciences’ Sunlenca Gains FDA Approval for HIV Type 1

The FDA has granted approval to Gilead Sciences’ Sunlenca (lenacapavir) for treatment of adults with human immunodeficiency virus (HIV) type 1 whose HIV infections can’t be treated with other available options because of resistance, intolerance or safety issues.

Sunlenca belongs to the capsid inhibitors drug class and blocks the HIV-1 virus protein shell.

The agency approval was supported by results from a phase 2/3 study, with 87.5 percent of participants taking Sunlenca experiencing a decrease in virus compared to 16.7 percent of participants taking placebo.

The FDA previously granted Sunlenca Priority Review, Fast Track and Breakthrough Therapy nods for this indication.