FDA accepts Sanofi and Regeneron’s biologics license resubmission

The US Food and Drug Administration (FDA) has accepted the resubmission of Sanofi and Regeneron Pharmaceuticals’ biologics license application for Kevzara (sarilumab) as a Class I response with a two month review timeline.

Per the prescription drug user fee act (PDUFA), the new target action date is May 22, 2017. Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor being evaluated 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 anti-rheumatic drugs (DMARDs), such as methotrexate.

EU approval

The companies recently received a positive opinion for Kevzara from the European Medicines Agency‘s Committee for Medicinal Products for Human Use, and the European Commission is expected to make a final decision on the marketing authorisation application for Kevzara in the European Union in the coming months.

Rheumatoid arthritis

In Canada, Kevzara is approved for use in adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.

The companies are also seeking approvals in a number of other countries globally.