Gilead Quad’s Side Effects Profile, Novel Agents To Get Advisory Committee Review

FDA’s Antiviral Drugs Advisory Committee takes up the four-drug HIV-1 regimen, which includes two new agents, on May 11. The firm hopes to be able to sell the combination in part on its favorable side effects profile if the product is approved.

A favorable adverse event profile in two head-to-head trials with other HIV treatment regimens could help Gilead Sciences Inc.’s four-active-ingredient HIV treatment Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) in its review by FDA's Antiviral Drugs Advisory Committee May 11, and in marketing if the drug is approved.

Quad has two unapproved ingredients; cobicistat is a novel boosting agent and elvitegravir is an investigational integrase inhibitor. But the one-to-one randomized, blinded, active-controlled design of the two pivotal Phase...

More from United States

More from North America