The EC approved Takeda and NPS Pharmaceuticals’ recombinant human glucagon-like peptide 2 (GLP-2) analog Revestive® (teduglutide) as a once-daily treatment for adults with short bowel syndrome (SBS). The drug is the first to be approved for this indication in Europe.
Regulatory clearance was based on data from the placebo-controlled Phase III Steps study in 43 SBS patients who required parenteral nutrition. Data showed that treatment with teduglutide more than doubled the percentage of patients who achieved a 20% to 100% reduction in parenteral nutrition at week 20 and 24, and reduced the volume of parenteral nutrition required by 4.4 liters per week. 54% of patients receiving teduglutide achieved an at least one-day reduction in parenteral nutrition, versus 23% of placebo-treated patients.
NPS Pharmaceuticals granted Nycomed (which was acquired by Takeda in September 2011) rights to develop and commercialize teduglutide outside the U.S., Canada, Mexico, and Israel in 2007. NPS retains all rights to the drug in North America, and submitted an NDA to FDA in November 2011, under the trade name Gattex®.