Once daily HIV ‘combo’ drug approved in U.S.

By Dr. Ananya Mandal, MDAug 11 2011

The U.S. Food and Drug Administration (FDA) has given its approval to a once daily HIV treatment that combines Gilead Sciences Inc.'s drug Truvada with Johnson & Johnson's drug Edurant, Gilead said Wednesday.

The $1,705-a-month drug combination is called Complera and it is approved for patients who have not previously been treated for HIV. Gilead's drug Truvada is a combination pill containing the drugs emtracitabine and tenofovir, and it was approved in August 2004. Edurant, or rilpivirine, was developed by Johnson & Johnson's Tibotec unit and was approved in May. Truvada and Edurant are both approved for use as part of a drug cocktail, but Wednesday's decision approves the drug as a stand-alone regimen.

According to Gilead, Complera is the second once-per-day drug intended for untreated HIV patients. The first was Atripla, which is marketed by Gilead and Bristol-Myers Squibb Co.

As of now, Gilead will be in charge of manufacturing, development and marketing in the U.S., European Union, Canada, Brazil, Australia and New Zealand. Tibotec can co-market Complera in those areas.

U.S. regulators first rejected Gilead's application for Complera in January, citing insufficient information. Also on Wednesday, the company said it has resolved all issues raised in an FDA warning letter from September. The FDA at the time raised concerns about manufacturing problems and product quality at a San Dimas, California, plant where Gilead makes many of its drugs. Now, the company's response and actions have “sufficiently addressed” FDA's concerns, Gilead said.

Around 33 million people worldwide have the human immunodeficiency virus, HIV, that causes AIDS, most living in Africa and Asia.