The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) sarilumab, branded as Kevzara, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
The specific recommended use for sarilumab is in combination with methotrexate (MTX) in adult RA patients who have failed to respond adequately to or are intolerant of one or more disease modifying anti-rheumatic drugs (DMARDs). Sarilumab can be administered as monotherapy in patients who are intolerant of MTX or when treatment with MTX is inappropriate.
A final decision from the European Commission usually takes ~60 days.
Kevzara is currently approved for sale in Canada. The marketing application in the U.S. is currently under FDA review.
SNY is up 5% premarket but only on 250 shares. No premarket action for REGN has been reported yet.