Common name: Tedulutide, Nycomine

Indications:

It is used to treat short bowel syndrome in which nutrients cannot be absorbed due to severe intestinal disease or large portion of small intestine resection.

September 5, 2012 - Takeda Pharmaceuticals, Japan's largest drugmaker, and its partner NPS Pharmaceuticals, Inc. announced that the Marketing Authorization application (MAA) for Revestive (teduglutide) has been approved by the European Commission. As a once-daily drug for the treatment of adults with short bowel syndrome (SBS).

On June 21 this year, Revestive's marketing authorization application (MAA) received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

Takeda will initially offer Revestive to patients in Europe through the NPP (Named Patient Program).

"Patients with short bowel syndrome (SBS) suffer from malnutrition and diarrhea and often require parenteral nutritional support to stay alive," says Palle Bekker Jeppesen, MD, Department of Gastroenterology, University of Copenhagen Medical School, Denmark. "Revestive is a novel, unique and important treatment option for our patients, while adding significant value to a limited number of therapeutic medical devices."

The first SBS drug approved in Europe

"Teduglutide is the first drug approved for SBS in Europe and provides a new and important treatment option for this patient population," said Trevor Smith, director of Takeda's Commercial Operations Centre for Europe and Canada.

"The approval of Teduglutide's European marketing application is great news for SBS patients," said Francois Nader, President and CEO of NPS Pharmaceuticals. "We look forward to working with our partner Takeda to launch this important product in the European market."

The marketing authorization application for Revestive is valid in member States of the European Union, and regulatory approval in Iceland and Norway is expected within 30 days.

The approval was based on a pivotal double-blind, placebo-controlled Phase III safety and efficacy trial in SBS patients requiring parenteral nutrition support. In the trial, 43 patients received subcutaneous injection of teduglutide at a dose of 0.05mg/kg/day and 43 patients received an injection of placebo for a total treatment period of 24 weeks.

The proportion of patients treated with Teduglutide who experienced a 20% to 100% reduction in parenteral nutrition support at weeks 20 and 24 was significantly higher than in the placebo group (60% vs 30%, p=0.002). At 24 weeks, patients treated with teduglutide had a 4.4 L/week reduction in parenteral nutritional support requirements, compared with 2.2 L/week in the placebo group. Twenty-one patients in the Teduglutide treatment group achieved a reduction of at least one day of parenteral application support (54%) compared to only nine patients (23%) in the placebo group. In the study, teduglutide was well tolerated in terms of dose, frequency and duration