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Regeneron Pharmaceuticals, Inc.

Partner : Sanofi-Aventis

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January 8, 2016
Regeneron and Sanofi Announce Sarilumab Biologics License Application Accepted for Review by US FDA

TARRYTOWN, N.Y. and PARIS, Jan. 8, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi today announced that the U.S. 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 program.

The goal of the ongoing global clinical development program 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.
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Source: press release, 1/08/16. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=949486

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Sarilumab (REGN-88) (2) RARheumatologyRheumatoid Arthritis (RA)IL-6 inhibitorIL-6R alpha

Mechanism of action: Sarilumab (REGN88/ SAR153191) is the first fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex (IL-6R alpha). Sarilumab is a high affinity, sub-cutaneously delivered, specific inhibitor of IL-6 signaling. It blocks the binding of IL-6 to its receptor and interrupts the resultant cytokine-mediated inflammatory signaling cascade.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-10-30

Results:

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REGENERON AND SANOFI RECEIVE COMPLETE RESPONSE LETTER FROM FDA FOR SARILUMAB, AN INVESTIGATIONAL TREATMENT FOR RHEUMATOID ARTHRITIS

TARRYTOWN, N.Y. and PARIS, Oct. 28, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The CRL refers to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished, one of the last steps in the manufacturing process. Satisfactory resolution of these deficiencies is required before the BLA can be approved. Sanofi submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that plan. Sanofi is working closely with the FDA towards a timely resolution that addresses these concerns. The CRL does not identify any concerns relating to the safety or efficacy of sarilumab.

Sanofi and Regeneron remain committed to the development of sarilumab and providing the therapy to RA patients in the U.S. as quickly as possible. If approved by the FDA, sarilumab would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.
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Source: press release, 10/28/16. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=996179

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