Takeda Pharmaceutical Company and NPS Pharmaceuticals have announced positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Teduglutide (Revestive) for patients with short bowel syndrome (SBS).
Teduglutide, which is a novel, recombinant analogue of human glucagon-like peptide 2 (GLP-2), gained orphan drug designation for the treatment of SBS from the EMA and FDA.
Takeda Europe & Canada commercial operations head Trevor Smith said, "We welcome the positive opinion from the CHMP for teduglutide. This is good news for patients with SBS."
The CHMP opinion was based upon data from the Pivotal phase 3 double-blind, placebo-controlled study, STEPS, in patients with SBS, who required parenteral nutrition.
The proportion of teduglutide treated subjects achieving a 20% to 100% reduction of parenteral nutrition at week 20 and 24 was statistically significantly different from placebo, (63% versus 30%, p=0.002).
NPS Pharmaceuticals president and chief executive officer Francois Nader said, "Teduglutide represents an important treatment advance that could significantly reduce or even eliminate parenteral nutrition support for patients with short bowel syndrome."
