Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Revestive Gets European Marketing Authorization For Short Bowel Syndrome

RELATED NEWS
Trade NPSP now with 

Takeda Pharmaceutical Company Ltd. and NPS Pharmaceuticals Inc. (NPSP: Quote) 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.

Register
To receive FREE breaking news email alerts for NPS Pharmaceuticals Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Stocks moved notably higher over the course of the trading day on Friday after initially showing a lack of direction. The gains on the day extended the recent upward trend by the markets, with the tech-heavy Nasdaq reaching its best closing level in almost a month. Looking to capitalize on news of an Ebola diagnosis in New York City, Republican Senate candidate Scott Brown issued a statement Friday criticizing his Democratic opponent Sen. Jeanne Shaheen, D-N.H., for "waffling" on a travel ban. In another troubling sign for Democrats, the results of a Gallup poll released on Friday show that Tea Party Republicans are much more motivated to vote in the upcoming midterm elections than other Americans. The poll found that 73 percent of Tea Party Republicans are "extremely" or "very" motivated to vote in this year's elections.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.