Takeda has received two bits of good news from the European Medicines Agency, including a positive opinion for potentially the first medical treatment for patients with short bowel syndrome in the continent.
The agency's Committee for Medicinal Products for Human Use has recommended approval of Takeda and partner NPS Pharmaceuticals' Revestive (teduglutide) for the treatment of adults with short bowel syndrome. The latter is a condition in which nutrients are not properly absorbed, due to severe intestinal disease or the surgical removal of a large portion of the small intestine. There are currently no medical treatments available.
Revestive was designated as an orphan drug in 2001 and the EMA notes that it gave "free scientific advice to the applicant during the development of the medicine". NPS hopes to get US approval for the drug, known there as Gattex, by the end of September.
Meantime, the EMA has granted marketing authorisation for Takeda's Rienso (ferumoxytol), an intravenous therapy to treat iron deficiency anaemia in adults with chronic kidney disease. The drug, which is licensed from AMAG Pharmaceuticals, is sold in the USA and Canada by Feraheme.
The approval triggers a $15 million milestone payment to AMAG from Takeda and the first commercial sale of Rienso in Europe will see the latter pocket another $15 million.