FDA Approves New Combination HIV Drug

The FDA has approved lamivudine and tenofovir disoproxil fumarate (Temixys, Celltrion) tablets, 300 mg/300 mg in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.

The approval of lamivudine and tenofovir disoproxil fumarate tablets authorizes bottles containing 30 once daily tablets. The approval also authorizes bottles containing 60 and 100 tablets for PEPFAR (President’s Emergency Plan for AIDS Relief) use, according to the FDA, in its approval letter to Celltrion, a biopharmaceutical developer in South Korea.

The FDA approved Celltrion’s application for approval on November 16, based on 2 bioavailability trials that demonstrated similarity in exposures between Temixys and its reference products: GlaxoSmithKline’s Epivir (lamivudine) and Gilead’s Viread (tenofovir disoproxil fumarate).

The most common adverse reactions (incidence greater than 10%, with lamivudine and tenofovir disoproxil fumarate) are headache, pain, depression, diarrhea, and rash, according to the Tamixys label.