Kevzara (sarilumab) is FDA approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis- Sanofi + Regeneron

Regeneron Pharmaceuticals, Inc and Sanofi announced the 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), such as methotrexate (MTX). Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA.

Kevzara may be used as monotherapy or in combination with MTX or other conventional DMARDs. The recommended dosage of Kevzara is 200 mg once every two weeks given as a subcutaneous injection, which can be self administered. The dosage can be reduced from 200 mg to 150 mg once every two weeks, as needed, to help manage certain laboratory abnormalities (neutropenia, thrombocytopenia, and liver enzyme elevations).

Comment: Kevzara (sarilumab), an IL-6 receptor antagonist, from Sanofi + Regeneron is now the first IL-6 receptor antagonist to be FDA approved 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.