Gilead asks FDA to approve blockbuster hopeful Quad against HIV

Gilead has taken another step forward with its HIV treatment known as Quad. The company ($GILD) revealed yesterday that it has filed for FDA approval of the potential blockbuster, a four-drug combo tablet that has been a main attraction in the HIV drugmaker's pipeline.

After success in cutting down viral loads in patients on the drug, Gilead has been moving full steam ahead with Quad in hopes of securing approval and releasing the treatment onto the market next year. The FDA is likely to give priority review to the drug, Leerink Swann analyst Joshua Schimmer said in a note to investors. Some analysts have lowered their market projections on Quad to a few hundred million dollars, unimpressed with its improvements over existing therapies. Still, many project that its sales will eventually exceed $1 billion if approved.

"Based on data from our pivotal studies, we believe that the Quad has the potential to be an important new treatment option for people living with HIV, and we are pleased to have reached this significant milestone less than six weeks after the unblinding of the second pivotal Phase 3 study," Norbert Bischofberger, Gilead's chief scientist, said in a statement.

Quad would be the first drug to combine the developmental integrase inhibitor elvitegravir with cobicistat, a booster drug, and Trumvada (Emtriva and Viread) in one tablet. In two pivotal studies, Quad met its primary goal of non-inferiority to Gilead and Bristol-Myers Squibb's ($BMY) blockbuster HIV drug Atripla. Gilead plans reveal full data from the pair of pivotal Quad studies at a scientific meeting next year.

- here's the release
- see Reuters' coverage

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