Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Release: Revestive® (teduglutide) Receives European Marketing Authorization for the Treatment of Adults With Short Bowel Syndrome (SBS)
9/4/2012 10:24:54 AM
OSAKA, Japan & BEDMINSTER, N.J.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502, “Takeda”) and NPS Pharmaceuticals, Inc. (NASDAQ: NPSP, “NPS”), jointly announced today that the European Commission (EC) has granted European market authorization for the medicinal product teduglutide (trade name in Europe: Revestive®) as a once-daily treatment for adult patients with short bowel syndrome. The marketing authorization follows a positive opinion issued on June 21, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following the authorization, Takeda intends to provide patient access to Revestive® within Europe initially through a Named Patient Program (NPP)*.