Newron Pharmaceuticals and fellow Italy-headquartered partner Zambon have filed their investigational Parkinson’s disease treatment safinamide with regulators in the USA.

The submission to the US Food and Drug Administration is for safinamide as add-on therapy in early and mid-to late stage PD patients. Newron said the filing was based on “completion of activities agreed upon during meetings” with the FDA, noting that a marketing authorisation application was submitted to the European Medicines Agency in December.

Ravi Anand, Newron's chief medical officer, said that following the usual review periods, “we are optimistic that safinamide will receive approval within Europe by end of this year, and in the US within 12 months”. Zambon has the rights to commercialise safinamide globally, excluding Japan and other Asian territories where they are held by Meiji Seika.

The FDA submission was made by Newron, which is the New Drug Application holder until completion of the process handing over the US rights to safinamide to Zambon. The latter linked up with Newron in 2012, a year after previous partner Merck Serono pulled out of its deal for the compound.