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11 Jan 2016

US FDA accepts Sanofi and Regeneron’s sarilumab BLA for review

Sanofi, a global healthcare leader, and Regeneron Pharmaceuticals, Inc., a leading science-based biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab. Per the Prescription Drug User Fee Act (PDUFA), the target action date is October 30, 2016. Sarilumab is an investigational, human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA). IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA and levels correlate with both disease activity and joint destruction.

The BLA for sarilumab contains data from approximately 2,500 adults with active, moderate-to-severe RA who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA phase 3 programme.

The goal of the ongoing global clinical development programme is to evaluate the safety and efficacy of subcutaneous sarilumab, either as monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX), in reducing the signs and symptoms and inhibiting the radiographic progression of RA.

The safety and efficacy of sarilumab have not been fully evaluated by any regulatory authority.

About Sarilumab

  • Sarilumab is a human monoclonal antibody against the interleukin-6 receptor.
  • Regeneron and Sanofi are currently co-developing the drug for the treatment of rheumatoid arthritis (RA), for which it is in phase III trials.
  • Development in ankylosing spondylitis has been suspended after the drug failed to show clinical benefit over methotrexate in a phase II trial.

Clinical trials

  • On May 15th, 2013, both companies announced that 2 new trials were starting (COMPARE and ASCERTAIN) and the first patients had already been enrolled.
  • In June 2015 a phase 3 trial (with methotrexate) for RA reported meeting its 3 coprimary endpoints.
  • In Nov 2015 the SARIL-RA-TARGET trial reported good results (meeting both its coprimary end points).

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