Rheumatoid Arthritis Drug Wins FDA Approval

The FDA has approved sarilumab (Kevzara) from Sanofi and Regeneron Pharmaceuticals for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to 1 or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MX).

The treatment can be used as monotherapy or in combination with MX or other DMARDs. Patients are recommended to take 200 mg once every 2 weeks given as a subcutaneous injection, which can be self-administered. The dosage can be reduced to 150 mg once every 2 weeks if needed.

Kevzara’s approval is based on 2, phase 3 trials involving 2900 adult patients that demonstrated statistically significant, clinically meaningful improvements in patients being treated with Kevzara plus background DMARDs.

The MOBILITY study, which evaluated Kevzara treatment plus MTX, showed reduced signs and symptoms, improved physical function, and less radiographic progression of structural damage in patients, compared to a placebo.

The TARGET study demonstrated reduced signs and symptoms and improved physical function with use of Kevzara plus DMARD, compared to a placebo plus DMARD.

Adverse effects observed in clinical studies included neutropenia, increased alanine aminotransferase, injection site erythema, upper respiratory infections, and urinary tract infections. Kevzara can also cause increased risk of serious infections that may lead to hospitalization or death.

Reference

Sanofi and Regeneron announce FDA approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients [news release]. Sanofi’s website. http://www.news.sanofi.us/2017-05-22-Sanofi-and-Regeneron-Announce-FDA-Approval-of-Kevzara-R-sarilumab-for-the-Treatment-of-Moderately-to-Severely-Active-Rheumatoid-Arthritis-in-Adult-Patients. Accessed May 23, 2017.