BioCentury
ARTICLE | Clinical News

Winfuran nalfurafine regulatory update

January 27, 2014 8:00 AM UTC

EMA said Toray withdrew an MAA for Winfuran nalfurafine to treat severe uremic pruritus in patients with end-stage kidney disease on dialysis. Last month, EMA's CHMP recommended against approval of Winfuran, saying that its benefits in the indication "had not been sufficiently shown" (see BioCentury, Jan. 6). The injectable formulation of the kappa opioid receptor agonist has Orphan Drug designation in the EU to treat hemodialysis-related uremic pruritus. Toray markets an oral formulation of the product in Japan as Remitch for the indication. ...