Winfuran nalfurafine regulatory update

On Dec. 19, 2013, EMA's CHMP recommended against approval of an MAA from Toray for Winfuran nalfurafine to treat severe uremic pruritus in patients with end-stage kidney disease on dialysis. The committee said the benefits of Winfuran in the indication "had not been sufficiently shown," noting that the main trial failed to show Winfuran was more effective than placebo in relieving itching. 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. ...