FDA clears Newron, Zambon, US WorldMeds' Xadago for Parkinson's disease

The FDA approved Newron Pharmaceuticals, Zambon and US WorldMeds' Xadago (safinamide) as an add-on therapy to levodopa/carbidopa for patients with Parkinson's disease, the companies announced Tuesday. Zambon global head of R&D Charlotte Keywood remarked "this first new treatment for a decade represents an important addition to the treatment choices for patients with [Parkinson's disease] and their doctors. 

The approval was supported by data from two randomised studies involving more than 1100 patients. Newron’s CMO Ravi Anand remarked "international, randomised, clinical trials have demonstrated that Xadago significantly improves on time, off time, and Parkinsonism compared to standard of care without increasing time spent with troublesome dyskinesia in patients experiencing motor fluctuations while on optimised levodopa/carbidopa therapy". 

Zambon inked a deal last year with US WorldMeds to jointly commercialise Xadago for the treatment of Parkinson's disease in the US. The FDA has previously declined to approve the drug and asked the drugmakers to evaluate the potential effect of the therapy on behaviours relating to abuse liability and dependence/withdrawal effects. The companies re-submitted Xadago to the FDA in September 2016. 

Meanwhile, the drug has been cleared by the European Commission and Swissmedic for the treatment of Parkinson's disease.