Sanofi and Regeneron Pharmaceuticals have resubmitted their Biologics License Application for Kevzara, which is an investigational human monoclonal antibody to be used for treatment of rheumatoid arthritis (RA) with adult patients.
The companies said Friday that the U.S. Food and Drug Administration has accepted the resubmission as a Class I response with a two month review timeline, with the Per the Prescription Drug User Fee Act (PDUFA), the new target action date is May 22, 2017.
The treatment is aimed for the RA patients who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate.
The European Medicine Agency’s Committee for Medicinal Products for Human Use has recently received a positive opinion for Kevzara.
The final decision by the European Commission is expected to be made on the Marketing Authorization Application for Kevzara in the European Union in the coming months.
The companies also said that they are seeking approvals in a number of other countries globally, as well.