RA: Sanofi/Regeneron IL-6R blocker FDA-approved
1.3 million Americans suffer from rheumatoid arthritis, @
Following the EMA’s recommendation for EU approval of sarilumab as second-line treatment for rheumatoid arthritis, French drug giant Sanofi and partner Regeneron have also been given the green light from the US FDA.
The immunosuppressant, which blocks IL-6 receptor-mediated signaling, was approved as treatment for adult patients with moderately to severely active rheumatoid arthritis (RA) who did not respond to disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate (MTX) sarilumab (trade name: Kevzara) may be used as monotherapy or in combination with MTX or other conventional DMARDs.
In two pivotal Phase III trials enrolling 2,900 patients, a combo of sarilumab plus DMARDs demonstrated statistically significant, clinically-meaningful improvements in patients with moderately to severely active RA. 61% and 66% of patients, who received 200 mg doses of the antibody, responded to the treatment (ACR20). Sanofi announced the treatment cost of “US$39,000/year for the 200 mg and 150 mg doses, is approximately 30% lower than the weighted average cost for the two most widely used TNF-alpha inhibitors”.
At the end of April, the European Medicines Agency (EMA) had give its recommendation for EU approval of sarilumab in RA. According to the agency, the benefits with Kevzara are its ability to reduce the signs and symptoms of rheumatoid arthritis and to improve physical function. Kevzara has been shown to inhibit the progression of joint damage in patients with rheumatoid arthritis. The most common side effects are neutropenia, increased ALT, injection site erythema, upper respiratory-tract infections, and urinary tract infections