logo
Plus   Neg
Share
Email

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Billionaire entrepreneur Elon Musk on Thursday showed off his concept for the Loop, a high-speed underground public transportation system that will carry up to 16 people and travel at 150 miles per hour. At the Boring Company Information Session, Musk and project leader Steve Davis provided details of the underground mass transit tunnels that the Boring Co. plans to build beneath Los Angeles. Raden has become the second smart luggage company to shut down this month after major U.S. airlines banned smart luggage with non-removable batteries earlier this year. In a statement on its website, Raden said that it is no longer in operation and that all existing shipments have been processed for delivery. The company is shuttering after three years of operation. Shares of AstraZeneca were losing around 2 percent in the London trading after the British drug major reported Friday lower profit in its first quarter amid weak margin, despite growth in product sales. Further, the company reiterated its outlook for fiscal 2018. The level of Externalisation Revenue, divestment timing and investment in launches impacted the overall results.
Follow RTT