The FDA approved Sanofi and Regeneron Pharmaceuticals’ interleukin-6 receptor (IL-6R)-targeting monoclonal antibody (mAb) Kevzara® (sarilumab) for treating adults with moderately to severely active rheumatoid arthritis (RA) who are intolerant to or who don’t respond adequately to one or more disease-modifying antirheumatic drugs (DMARDs). Clearance by the U.S. regulator was based on data from the Phase III MOBILITY and TARGET studies, which showed that treatment using Kevzara plus either methotrexate or a DMARD reduced the signs and symptoms of RA, compared with treatment using either methotrexate or DMARD therapy alone.
FDA approval covers use of Kevzara either as monotherapy or combined with methotrexate or other DMARDs. The drug will be marketed by Regeneron and Sanofi Genzyme in the U.S. at a wholesale acquisition cost (WAC) of $39,000 per patient per year, which the companies say is about 30% lower than the WAC for the two most widely used tumor necrosis factor-α (TNF-α) inhibitors.
“In the clinical trial program, sarilumab demonstrated statistically significant, clinically meaningful improvements in adult patients with rheumatoid arthritis by reducing signs and symptoms and improving physical function, resulting in significantly less radiographic progression of structural damage of RA,” said Alan Kivitz, M.D., CPI, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center, and an investigator in the global SARIL-RA clinical program for sarilumab. “Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF class and is a welcome new option for patients and their physicians.”
Kevzara was approved in Canada in February and has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The drug’s progress along the U.S. regulatory pathway hit a stumbling block last year when the FDA issued a complete response letter (CRL) to the firms’ initial biologics license application, citing deficiencies at Sanofi’s fill/finish facility in Le Trait, Rouen in France. The application was resubmitted in March following corrective actions by Sanofi and reinspection of the site by the FDA.
“Today's milestone with Kevzara, which follows closely on the heels of our recent approval of Dupixent® (dupilumab), showcases the ability of our internal discovery and science engine to deliver important new medicines by leveraging our leading technologies, such as VelocImmune®,” added George D. Yancopoulos, M.D., Ph.D., founding scientist, president, and CSO at Regeneron.
Approval of Kevzara in the U.S. follows just a couple of months after Sanofi and Regeneron won FDA clearance for their monoclonal antibody Dupixent as a treatment for moderate-to-severe atopic dermatitis. In March, the firms reported that patients with severe atopic dermatitis in the U.K. would be granted access to dupilumab through the Early Access to Medicines Scheme (EAMS) before full marketing authorization is granted.
The firms’ therapeutic antibody partnership, established in 2007, has also resulted in development of the cholesterol-lowering PCSK9-inhibiting antibody Praluent® (alirocumab), which is now approved in more than 50 countries. Last month, the FDA approved the firms' supplemental BLA for a once-monthly dosing option.