CHMP recommends Newron's safinamide for PD

EMA's CHMP recommended marketing authorization of safinamide from Newron Pharmaceuticals S.p.A. (SIX:NWRN) and partner Zambon Co. S.p.A. (Bresso, Italy) 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.

CHMP said the marketing authorization will include a pharmacovigilance plan. ...