Zambon submits MAA for Newron's safinamide

Newron Pharmaceuticals S.p.A. (SIX:NWRN) and partner Zambon Co. S.p.A. (Bresso, Italy) said Zambon submitted an MAA to EMA for safinamide to treat Parkinson's disease (PD). The MAA covers safinamide as add-on therapy to a stable dose of a dopamine agonist for patients with early PD; and as add-on therapy to levodopa alone or in combination with other treatments in patients with mid- to late-stage PD.

Zambon has exclusive rights from Newron to develop and commercialize safinamide worldwide, excluding Asian territories where Meiji Seika Pharma Co. Ltd. (Tokyo, Japan) has rights. The product is an alpha-aminoamide derivative that acts as a reversible monoamine oxidase B (MAO-B) and dopamine reuptake inhibitor while reducing glutamatergic activity. ...