Gilead Sciences ($GILD) has notched a victory in the company's campaign for Quad. The four-in-one pill for HIV won support from an FDA advisory committee Friday, bolstering the Foster City, CA-based company's efforts to gain approval of the drug and maintain its top position in the market for HIV and AIDS drugs.
The FDA's Antiviral Drugs Advisory Committee voted 13-1 that Quad is a safe and effective drug for HIV patients who haven't received prior treatment for the immune system-attacking disease. U.S. regulators weigh such non-binding advice in the agency's decisions on drug approvals, and the FDA is expected to take action on Gilead's application for Quad by August 27.
Gilead's future success in the HIV market relies heavily on the approval of Quad, which could provide the company with a $1 billion-plus seller after patents on its top-selling drug Atripla expire. With Quad, Gilead combines four of its compounds--the experimental integrase inhibitor elvitegravir and boosting agent cobicistat, as well as the approved Truvada, which includes emtricitabine and tenofovir disoproxil fumarate. The drug is the first single tablet, once-daily drug that delivers an integrase inhibitor, according to Gilead.
"With new government guidelines recommending that people diagnosed with HIV begin treatment early, it is important that we continue to simplify and improve HIV therapy," said Gilead's HIV therapeutics chief Dr. Andrew Cheng said in a statement. "The Quad is the latest example of Gilead's ongoing efforts to develop highly effective and well tolerated single tablet regimens for people living with HIV."
In a late-stage clinical study, Quad was 88% effective in stymying HIV, compared with 84% disease suppression in patients on Gilead's drug three-drug combo drug Atripla. Yet there are concerns that more patients on Quad suffered kidney problems in studies and that female patients were under-represented in trials. As Reuters reports, regulators could require patients on Quad to be monitored for kidney damage.
"There are plenty of alternatives to Quad," said Dr. Michelle Estrella, of Johns Hopkins University School of Medicine, as quoted by Reuters. Estrella was the only FDA panel member to vote against approval of Quad. "There's no huge hurry in approving this drug before the outstanding studies are completed."
Gilead triumphed at two advisory committee sessions this week, having won the FDA panel's backing on Thursday for approval of Truvada as a preventive therapy for patients at risk of getting HIV.
- here's the release
- check out Reuters' article