Swissmedic approves Xadago for use in Parkinson's disease

CNS specialist Zambon and its partner, fellow Italy-based Newron Pharmaceuticals (NWRN: SIX) have announced that Switzerland’s regulator Swissmedic has approved Xadago (safinamide) as add-on therapy to levodopa (L-dopa) alone or in combination with other PD therapies for patients with Parkinson’s disease in mid-to late-stage and motor fluctuations.

The approval in Switzerland was preceded by the marketing authorization throughout the European Union by the Commission of the EU, in February 2015. Xadago was also accepted for review by the US Food and Drug Administration and has a current Prescription Drug User Fee Act PDUFA date of March 29, 2016, after the FDA extended the review time for the Xadago to review the late submission of additional financial disclosure forms for two clinical studies (The Pharma Letter September 30).

Maurizio Castorina, chief executive of Zambon, stated: “This approval by Swissmedic is a further evidence of the acceptance of the benefits offered by Xadago (safinamide) by another regulatory authority. We keep on working to ensure this new chemical entity will be available to all the patients in need of innovative therapies in Parkinson’s disease.”