logo
Share SHARE
FONT-SIZE Plus   Neg

Revestive Gets European Marketing Authorization For Short Bowel Syndrome

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

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Bank of Nova Scotia or otherwise known as Scotiabank, Friday reported lower net profit for the third quarter, in the absence of a year-ago gain. Earnings per share, however, came in line with the Street view. Further, the company said it raised its quarterly dividend by 2 cents. Non-traditional discount and variety stores operator Big Lots Inc. (BIG) Friday reported a decline in net profit for the second quarter, while net sales grew 1.2 percent from the prior year. Comparable sales for the quarter increased 2.8 percent. Google has rejected the European Union's charges that it abused its market power and the demanded that it change the way it ranks online comparison shopping services in its search results, setting up a potentially long legal battle with the EU regulator empowered to levy billions of euros in fines
comments powered by Disqus
Follow RTT