The Food and Drug Administration has approved a once-per-day HIV treatment that combines Gilead Sciences Inc.’s drug Truvada with Johnson & Johnson’s drug Edurant, The Associated Press reports.
Meantime, Gilead, with Branford operations, has resolved the manufacturing issues that led the Food and Drug Administration to send the company a warning letter in September, The AP reports.
The combination pill 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.
Gilead said 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.
The FDA had warned Gilead about quality-control violations at a facility in San Dimas, Calif. The violations could have affected Gilead’s ability to export the antifungal drug AmBisome. The agency found the manufacturing problems during an inspection in early 2010. It later said Gilead’s response to those problems was not sufficient.
AmBisome is an injectable drug, and Gilead said the problems would not have affected tablets, including its HIV drugs Atripla and Truvada.
