TARRYTOWN, NY, USA and PARIS, France I January 26, 2015 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for PraluentTM (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia.
The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years.
Earlier this month, the companies announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals
Post Views: 128
TARRYTOWN, NY, USA and PARIS, France I January 26, 2015 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for PraluentTM (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia.
The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years.
Earlier this month, the companies announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals
Post Views: 128
