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 FDA and has a current PDUFA date of March 29, 2016.
Maurizio Castorina, CEO 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.”
Stefan Weber, CEO of Newron, added: “We are delighted that PD patients in Switzerland will now have access to this innovative treatment offering unique benefits.”
Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition, use-dependent Na channels blockade and Ca channels modulation which lead to modulation of abnormal glutamate release. Clinical trials have unequivocally established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect also in the long term (over 2 years). Results from long-term (24 months) double-blind controlled studies suggest that safinamide shows significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This positive effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is well tolerated with a favourable side-effect profile and is easy to use: once-daily dose, no need of LD adjustment, no major drug–drug interactions, no diet restrictions due to its higher MAO-B/MAO-A selectivity.