FDA HAS APPROVED SUNLENCA (LENACAPAVIR), A NEW ANTIRETROVIRAL DRUG FOR THE TREATMENT OF HIV-1 IN ADULT PATIENTS WHO HAVE NOT RESPONDED TO OTHER TREATMENTS

The US Food and Drug Administration (FDA) has approved Sunlenca (lenacapavir), a new antiretroviral drug for the treatment of human immunodeficiency virus type 1 (HIV-1) in adult patients who have not responded to other treatments due to resistance, intolerance, or safety concerns. Sunlenca is the first drug in a new class of capsid inhibitors to be approved for treating HIV-1. It works by blocking the capsid, the protein shell of the virus, and disrupting various stages of the viral lifecycle. It is given as a combination therapy with other antiretrovirals, with a starting dose of oral tablets and subcutaneous injections followed by maintenance injections every six months. The drug's safety and effectiveness were established in a clinical trial involving 72 patients with HIV infections resistant to multiple classes of HIV medications. The most common side effects of Sunlenca were injection site reactions and nausea. Sunlenca has been granted Priority Review, Fast Track, and Breakthrough Therapy designations by the FDA and has been approved for marketing by Gilead Sciences.

References: https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-drug-adults-limited-treatment-options