According to BioSpace, the FDA has accepted for review a supplemental Biologics License Application (sBLA) for rilonacept (Arcalyst®) subcutaneous injection for the prevention of gout flares in patients initiating uric acid-lowering therapy.

The submission is based on data from a Phase III North American study (PRE-SURGE 1) and a global Phase III study (PRE-SURGE 2), in which 488 patients initiating uric acid-lowering therapy were randomised to receive one of two doses of rilonacept (160mg stat followed by 80mg weekly or 320mg stat followed by 160mg weekly) or placebo for 16 weeks.  Both met the primary endpoint of reduction in the mean number of gout flares per patient during the 16-week treatment period (please see the link below for details).