FDA approves Newron's Xadago

FDA approved Xadago safinamide from Newron Pharmaceuticals S.p.A. (SIX:NWRN) as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing "off" episodes.

In March 2016, FDA issued a complete response letter for the therapy. Newron said the agency requested clinical evaluation of Xadago's potential effects on behaviors relating to abuse liability, and its dependence and withdrawal effects. The company re-submitted the application in September (see BioCentury Extra, Sept. 22, 2016)...