Potential Rheumatoid Arthritis Therapy Under FDA Review

Potential Rheumatoid Arthritis Therapy Under FDA Review

Regeneron Pharmaceuticals, Inc., and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for sarilumab, an investigational, human monoclonal antibody intended to treat patients with active, moderate-to-severe rheumatoid arthritis (RA).

Under the stipulations of the Prescription Drug User Fee Act (PDUFA), the target date for a decision is Oct. 30, 2016.

The BLA was supported by data from clinical trials involving some 2,500 RA patients with inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA Phase 3 trial program, Regeneron said in a press release.

In mid-2015, the two biopharmaceutical companies released positive results from the SARIL-RA-TARGET clinical trial in 546 patients showing that the IL-6 receptor antibody significantly improved RA-associated symptoms. IL-6 is the most abundant cytokine in the serum and synovial fluid of RA patients, and its levels correlate with disease activity and joint damage.

In addition, two other studies — SARIL-RA-EASY and SARIL-RA-ASCERTAIN — were reported to have successfully achieved their primary endpoints. The SARIL-RA-ASCERTAIN, with 202 participants, determined the safety and efficacy of sarilumab as a monotherapy or as a combined therapy — combining conventional disease-modifying anti-rheumatic drugs (DMARDs) with subcutaneous injections of sarilumab in patients previously identified as intolerant to TNF-alpha inhibitors. The SARIL-RA-EASY, with 217 patients, evaluated the performance and outcome of a sarilumab auto-injector device.

The full safety and efficacy profile of sarilumab has not yet been evaluated by any regulatory authority.

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