Takeda Pharmaceutical Company Ltd. and NPS Pharmaceuticals Inc. (NPSP) said the European Commission or EC has granted European market authorization for the medicinal product teduglutide or 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 or CHMP of the European Medicines Agency or EMA. Following the authorization, Takeda plans to provide patient access to Revestive within Europe initially through a Named Patient Program or NPP.
"Short Bowel Syndrome patients suffer from malnutrition and diarrhoea, and often parenteral nutrition is necessary to maintain life," said Professor Palle Bekker Jeppesen, M.D., Ph.D, Department of Medical Gastroenterology, Rigshospitalet, University Hospital of Copenhagen, Denmark.
The marketing authorization would be held by Nycomed Danmark ApS+ and is valid in the current EU Member States. National approvals are expected in Iceland and Norway within 30 days. It is based on data obtained from the STEPS pivotal Phase 3 safety and efficacy study, a double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition.
by RTT Staff Writer
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