Newron and Zambon file safinamide NDA with FDA

Italian drug developer Newron Pharmaceuticals (SIX: NWRN) and its partner, family-owned Italian drugmaker Zambon revealed that the New Drug Application for safinamide was submitted today to the US Food and Drug Administration.

The submission covers the indications “safinamide as add-on therapy to a stable dose of a single dopamine agonist” in early Parkinson’s disease patients and “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients. The submission was based on completion of activities agreed upon during meetings with the FDA.

The submission was made by Newron, which is the NDA holder until completion of the sublicense process for the US rights to safinamide by Zambon.