With an FDA panel looming, agency staff raised concerns about the risk of kidney damage seen in studies of Gilead Sciences' ($GILD) HIV treatment Quad. The staff review comes days ahead of a panel of non-agency experts who will decide whether to back approval of the new four-drug pill, which could sure up Gilead's position as the leading maker of AIDS drugs for years to come if approved later this year.
The kidney damage could warrant monitoring of patients taking the drug, the FDA staff briefing said, according to Bloomberg. Studies showed that more kidney problems were seen among patients on Quad than other HIV meds, including four patients who suffered kidney failure and one who developed a rare condition that caused renal problems. However, fewer patients quit taking Quad in studies because of side effects than existing meds, a plus for Gilead's case for the combo pill to provide a safer option for treating patients.
Gilead has captured headlines this year for its nearly $11 billion buyout of Pharmasset to gain a footing in the hot field of oral hepatitis C treatments, yet the California biotech company's bread and butter has long been drugs for HIV. Quad offers Gilead a chance to keep the company's reign in the HIV market alive after its patents for top-seller Atripla end, Reuters reported. Also, Quad consists of four Gilead drugs and is taken once a day, while Atripla combines Gilead's two-drug treatment Truvada with Bristol-Myers Squibb's ($BMY) Sustiva.
The advisory panel meets on Friday to discuss Quad, and the FDA will factor in the panel's votes in the agency's decision on approval expected by Aug. 27, Bloomberg reported. Gilead's experimental drug is expected to become a blockbuster product if approved.