ARTICLE | Company News
FDA again reviewing Newron's Xadago for Parkinson's
October 21, 2016 7:00 AM UTC
Newron Pharmaceuticals S.p.A. (SIX:NWRN) said FDA accepted its re-submitted NDA for Parkinson's disease candidate Xadago safinamide. Its PDUFA date is March 21, 2017.
In March, the agency issued a complete response letter for the compound, which was under review as an add-on therapy for early and mid to late stage PD in patients who are inadequately managed on their current treatments. Safinamide is an alpha-aminoamide derivative that acts as a reversible monoamine oxidase B ( MAO-B) and dopamine reuptake inhibitor while reducing glutamatergic activity. Newron resubmitted the application in September (see BioCentury Extra, March 29). ...