Newron re-submits US NDA for Xadago

Italian CNS and pain focussed drugmaker Newron Pharmaceuticals (SIX: NWRN) and its partners Zambon and US WorldMeds announced today that Newron has re-submitted the New Drug Application (NDA) for Parkinson’s disease drug Xadago (safinamide) to the US Food and Drug Administration FDA.

As previously reported, the FDA communicated to Newron in a meeting in July that clinical studies to evaluate the potential abuse liability or dependence/withdrawal effects of Xadago were no longer required. The meeting had been scheduled following the March 29, 2016 Complete Response Letter (CRL) by the FDA. The FDA agreed that the re-submission did not require any new data/studies/analyses for efficacy or safety in patients with Parkinson’s disease. As a class 2 resubmission, the FDA is expected to complete its review of the re-submission within six months of acceptance.

Zambon has the rights to develop and commercialize Xadago globally, excluding Japan and other key territories where Meiji Seika has the rights to develop and commercialize the compound. The rights to develop and commercialize Xadago in the USA have been granted to US WorldMeds, by Zambon. Xadago has already received marketing authorization for the treatment of Parkinson’s disease in the European Union, where it was first launched in 2015, and Switzerland.