The FDA has accepted the resubmission of the Biologics License Application for Kevzara (sarilumab) for the treatment of rheumatoid arthritis.- Sanofi + Regeneron

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the FDA has accepted the resubmission of 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 22 May , 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 antirheumatic drugs (DMARDs), such as methotrexate.

The companies recently received a positive opinion for Kevzara from the European Medicine Agency's Committee for Medicinal Products for Human Use, and the European Commission is expected to make a final decision on the Marketing Authorization Application for Kevzara in the European Union in the coming months. 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.

Comment: Kevzara is likely to be the first IL-6 receptor antagonist to be approved in the US and now has CHMP recommendation in the EU. The lack of differentiation with Actemra may inhibit sales as both drugs performance is similar (non responders to TNF antagonists) and unless there is a price difference or a head to head trial this may not be resolved. Also Actemra patents expire in 2022 opening the market to low cost tocilizumab biosimilars from Epirus, Mycenax and OncoBiologics. Competitors at present are sirukumab from GSK filed in EU and US and a further new product which is baricitinib, a JAK 1/2 inhibitor from Eli Lilly + Incyte, whose progress is delayed by a recent Complete Response Letter from the FDA.