CHMP recommends approval of Newron/Zambon's Xadago for Parkinson's disease

Italy-based Newron Pharmaceuticals (NWRN: SIX) and its partner Zambon have received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) that the European Commission approve Xadago (safinamide).

The drug is recommended as an add-on to L-dopa alone or in combination with dopamine agonists, entacapone, amantadine, and/or anticholinergics, for the treatment of patients with mid-late stage Parkinson's disease experiencing motor fluctuations despite being stabilized on 'standard of care.'

Ravi Anand, chief medical officer of Newron, said: "The CHMP decision on safinamide is a great result for PD patients and physicians, providing them with a therapeutic alternative that is an improvement over "standard of care" in patients with mid-late stage Parkinson's disease patients on L-dopa, who constitute a major proportion (over 75%) of those that are experiencing this progressive debilitating disease. Safinamide's unique profile of rapid onset and long lasting efficacy, significant even at two years, in a randomized placebo-controlled trial, has not been demonstrated with any other PD medication. In addition, safinamide improved patient and care giver rated Quality of Life measures, including PDQ39 and EQ-5D, as well as depressed mood. We thank the CHMP and EMA staff for their scientific advice during the development of safinamide and performing a timely review of the MAA."