PropThink: Previewing Gilead's 'Quad' Ahead of FDA Decision

On August 27th the FDA is set to decide on whether to approve Gilead Science’s (NASDA:GILD) pending HIV treatment, the Quad.  If approved, the Quad will be the first once-daily integrase inhibitor, a type of treatment that prevents the Human Immunodeficiency Virus (HIV) from bonding with the host’s DNA and ultimately inhibits the spread of the virus. It is a combination of four products from Gilead, who submitted a New Drug Application (NDA) for the Quad in October of last year. In May, an FDA advisory panel recommended approval by a vote of 13-1, but encouraged further studies testing the drug’s safety in women, as females were largely underrepresented in clinical trials. They also encouraged monitoring of patients on the Quad for kidney problems, as it has shown an increase in serum creatinine which affects the renal system. (more…)