EC approves Zambon and Newron's Xadago for late-stage PD patients

Zambon and its partner, fellow Italy-based Newron Pharmaceuticals (NWRN: SIX), have received approval fromthe European Commission approved the use of Xadago(safinamide) for the treatment of idiopathic Parkinson’s disease (PD).

Xadago has been approved for mid-to late-stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products. The decision f ollows the Positive Opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) and is applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.

Ravi Anand, Newron’s chief medical officer, commented: “We're extremely pleased to see the European Commission’s approval, providing a next generation, innovative add-on treatment option to PD patients. Xadago(safinamide) is the first add-on treatment for PD showing both rapid onset of efficacy and improvements in ‘ON and OFF Time’, without any increase in dyskinesia for at least two years, compared with ‘Standard of Care’, as demonstrated in a double-blind trial in patients receiving optimized treatment for PD. The compound’s dual mechanism includes highly selective, reversible inhibition of MAO-B, and state and use-dependent blockade of sodium channels; the latter action leads to inhibition of stimulated release of glutamate. As excessive glutamate release is implicated in the etiology of dyskinesia, Xadago (safinamide) could prevent or attenuate L-dopa induced dyskinesia in PD patients.”

Late last year, Newron and Zambon re-submitted their New Drug Application for safinamide to the US Food and Drug Administration following a previous ‘Refusal to File’ notification from the agency, due to organizational and navigational problems because of hyperlinking of tables, folders and the way the table of contents in the submission was organized.