European Advisory Committee Recommends Parkinson’s Disease Drug Xadago

European Medicines Agency advisors recommended approval of Newron and Zambon Pharmaceuticals’ Parkinson’s disease drug Xadago in combination with levodopa or other therapies for mid- to late-stage patients experiencing motor fluctuations.

Xadago (safinamide) is the first new chemical entity for the disease to receive the EMA Committee for Medicinal Products for Human Use’s blessing in 10 years, the companies said Wednesday. The drug is unique in that it both inhibits an enzyme that breaks down dopamine and blocks sodium channels from causing involuntary muscle movements, they added.

The positive recommendation was based on several large international placebo-controlled studies of patients on Xadago, levodopa alone or other Parkinson’s medications. Those on Xadago demonstrated improved results within two weeks, including stabilization of involuntary movements, the companies said.

The application now goes to the European Commission for a final decision. — Lena Freund