GSK's Two-Drug HIV Therapy Dolutegravir/Rilpivirine Approved in China

Intelligency Finance APP learned that on October 21, the official website of China's National Medical Products Administration (NMPA) announced the approval of the new drug application for a dual-drug HIV therapy — Dolutegravir and Rilpivirine Tablets, submitted by GlaxoSmithKline (GSK). According to the priority review announcement by the Center for Drug Evaluation (CDE) under China’s NMPA, the approved indication is for the treatment of specific adult patients infected with Human Immunodeficiency Virus Type 1 (HIV-1). Notably, this medicine is also the first dual-drug therapy approved by the FDA for maintenance treatment in virologically suppressed patients. Compared with HIV treatment regimens containing no fewer than three drugs, limiting the number of drugs in HIV therapies is expected to reduce toxicity to patients.

In China, GSK submitted a new drug application for Dolutegravir and Rilpivirine Tablets in January 2021. The application was subsequently granted priority review by the CDE for the treatment of adult patients with HIV-1 infection who have achieved virologic suppression (HIV-1 RNA less than 50 copies/mL) for at least six months on a stable antiretroviral regimen, with no history of virologic failure and no known or suspected resistance to NNRTIs or integrase inhibitors.

The approval of GSK's Dolutegravir and Rilpivirine Tablets in China is expected to bring new treatment options to more HIV-infected patients.