USA: FDA panel votes against Regeneron gout drug; Court upholds Abilify patent

The US Food and Drug Administration’s Arthritis Advisory Committee yesterday voted unanimously (11 to 0) against approval of US drugmaker Regeneron Pharmaceuticals’ (Nasdaq: REGN)  Arcalyst (rilonacept) injection for subcutaneous use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy.

The Committee's recommendation will be considered by the FDA in its review of the supplemental Biologics License Application for Arcalyst, but the Committee's recommendation is not binding on the FDA. Regeneron has been granted a target date for an FDA decision of July 30, 2012.

Committee members also voted six to five that Arcalyst works to treat gout flares and eight to three that Regeneron’s safety data on the treatment are inadequate. Additionally, the panel also suggested that the drugmaker possibly limit Arcalyst’s use to patients who can’t take the other therapies