Sanofi & Regeneron Announce Biologics License Application Resubmission is Accepted for Review
Sanofi and Regeneron Pharmaceuticals, Inc. recently announced that the US FDA has accepted the resubmission of Biologics License Application for Kevzara (sarilumab) as a Class I response with a 2-month review timeline. Per the Prescription Drug User Fee Act (PDUFA), the new target action date is May 22, 2017. Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor being evaluated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate.
The companies recently received a positive opinion for Kevzara from the European Medicine Agency’s Committee for Medicinal Products for Human Use, and the European Commission is expected to make a final decision on the Marketing Authorization Application for Kevzara in the European Union in the coming months. In Canada, Kevzara is approved for use in adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs. The companies are also seeking approvals in a number of other countries globally.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.
Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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