CHMP recommends EU approval of Revestive (Nycomed) for treating Short Bowel Syndrome

The CHMP has recommended granting marketing authorisation for Revestive (teduglutide), from Nycomed, as a once-daily treatment for adult patients with Short Bowel Syndrome (SBS). The marketing authorisation application was submitted in March 2011. The CHMP opinion was based upon data from STEPS, the pivotal Phase III study in patients with SBS, who required parenteral nutrition; 43-patients were randomised to a subcutaneous 0.05-mg/kg/day dose of teduglutide and 43-patients to placebo for up to 24-weeks. 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%). Teduglutide has received orphan drug designation for the treatment of SBS from the EMA and the FDA.