Gilead Sciences Files NDA

Gilead Sciences shares were over 1% higher Monday after the drug maker said it filed a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination treatment for HIV-1 infection in adults. The fixed-dose combination treatment is part of a once-daily single tablet regimen which may have potential to advance triple-therapy HIV treatment for a broad range of patients, the company said.

Gilead chief scientific officer Norbert Bischofberger said, “we aim to simplify the management of HIV for a broad range of patients with this single tablet regimen that combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the [emtricitabine/tenofovir alafenamide] FTC/TAF backbone.” The company also said it plans to submit a marketing authorization application for the combination treatment in the European Union in Q3.

By Kristen Tardella