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European advisory committee backs Sanofi's diabetes med Suliqua

Published 11/11/2016, 09:11 AM
European advisory committee backs Sanofi's diabetes med Suliqua
SASY
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  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Sanofi 's (NYSE:SNY) Suliqua (iGlarLixi) for the treatment of adults with type 2 diabetes. The specific indication is the use of Suliqua, in combination with metformin, for the treatment of adult type 2 diabetics to improve glycemic control when treatment with metformin alone or in combination with another oral glucose-lowering medicine or basal insulin fails to do the job.
  • Suliqua is a once-daily fixed-dose combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide.
  • A final decision from the European Commission usually takes ~60 days.
  • The company's New Drug Application (NDA) in the U.S. is currently under review.
  • Lixisenatide was invented by Zealand Pharma (OTCPK:ZLDPF). Sanofi secured global commercialization rights under a 2003 license agreement.

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