Safinamide regulatory update

Newron and partner Zambon announced the resubmission of an NDA to FDA for safinamide to treat Parkinson’s disease. The application covers the use of safinamide as an add-on therapy to a stable dose of a single dopamine agonist for patients with early PD and as an add-on therapy to levodopa alone or in combination with other PD treatments in patients with mid- to late-stage PD. FDA had issued a refusal to file letter after the first NDA submission last May. The partners said the letter was based on organizational and navigational problems with the submission. ...