Regeneron, Sanofi Announce FDA Has Accepted For Review BLA For Sarilumab

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA (ADR) (NYSE: SNY) jointly announced Friday morning that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) for sarilumab.

Regeneron noted that the BLA for sarilumab contains data from around 2,500 adults with active, moderate or severe rheumatoid arthritis who had an inadequate response to prior treatment regimens.

"The goal of the ongoing global clinical development program is to evaluate the safety and efficacy of subcutaneous sarilumab, either as monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX), in reducing the signs and symptoms and inhibiting the radiographic progression of RA," Regeneron stated.

Shares of Regeneron were trading higher by 0.63 percent at $505.11 Friday morning, while shares of Sanofi were trading lower by 0.58 percent at $41.09.