Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), …
Tag Archives: sarilumab
May, 2017
October, 2016
-
31 October
FDA Rejects Sanofi and Regeneron’s Rheumatoid Arthritis Drug due to Manufacturing Concerns
Paris and Tarrytown, N.Y. – October 28, 2016 – Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with …
March, 2016
-
11 March
Regeneron and Sanofi’s RA Drug Meets Primary Endpoint in Late-Stage Trial
TARRYTOWN, N.Y. and PARIS, March 11, 2016 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Phase 3 monotherapy study met its primary endpoint demonstrating that sarilumab was superior to adalimumab (marketed by AbbVie as HUMIRA®) in improving signs and symptoms in patients with active rheumatoid arthritis …