Sanofi and Regeneron Pharmaceuticals has announced that the FDA has accepted the resubmission of the biologics licence application for Kevzara (sarilumab) as a Class I response with a two-month review timeline.
Accepted tick
Recently, a positive opinion for the drug was given by the EMA’s CHMP and the European Commission is expected to make a final decision on the marketing authorisation application in the coming months. Kevzara is already approved for use in Canada and the companies are seeking approvals in a number of other global countries.
Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor currently under evaluation 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).