FDA Approves Xadago® for Parkinson’s Disease Patients

Newron Pharmaceuticals S.p.A. ("Newron", SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, and its partners Zambon S.p.A. and US WorldMeds, LLC, announced that the Food and Drug Administration (FDA) has approved the use of Xadago® (safinamide) for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa. Parkinson’s disease affects an estimated 7 to 10 million patients worldwide, of whom 1 million are in the U.S.A.

C. Warren Olanow, M.D. FRCPC, FRCP(HON), stated: "The approval of Xadago® as a treatment for patients with Parkinson’s disease by the FDA represents an important milestone as it is the first New Chemical Entity approved for the treatment of Parkinson’s disease in the USA in over a decade." Dr. Olanow, Professor and Chairman Emeritus of the Department of Neurology and Professor Emeritus of the Department of Neuroscience at the Mount Sinai School of Medicine in New York City continued, "Xadago® as an add-on to levodopa/carbidopa provided a significant reduction in OFF time and a significant increase in ON time without troublesome dyskinesia in PD patients experiencing motor fluctuations."

Ravi Anand, Newron’s CMO, commented: "International, randomized, 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 optimized levodopa/carbidopa therapy. Additionally, the onset of improvement of motor fluctuations occurred early in treatment."

P. Breckinridge ("Breck") Jones, CEO of US WorldMeds said: "We are thrilled by the FDA’s approval of Xadago® and are excited to have a key role in the introduction of a new medicine for Parkinson’s disease. We will now accelerate our US launch preparations to get Xadago® to Parkinson’s patients in need of new treatment options."

Dr Charlotte Keywood, Global Head R&D, Zambon, said: "We are delighted with the approval of Xadago® in the USA. This first new treatment for a decade represents an important addition to the treatment choices for patients with PD and their doctors. In order to more fully characterize the clinical benefits of Xadago®, Zambon will continue to work with our partners on new clinical trials."

Marketing authorization in the EU for Xadago^® was granted by the EU Commission in February 2015, and by Swissmedic in November 2015. Following the 2015 European approval and the launch in Germany, Xadago^® has been launched by Zambon in 10 further European markets in 2016 including Italy, Spain, UK, Belgium, Denmark, Sweden, Luxembourg, the Netherlands, Norway, and Switzerland.