Newron Pharmaceuticals, 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 SpA and US WorldMeds, have announced that the US 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 7–10 million patients worldwide, of whom 1 million are in the USA.
Warren Olanow, MD, 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 more than 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, randomised, clinical trials have demonstrated that Xadago significantly improves ON time, OFF time, and Parkinsonism compared with standard of care without increasing time spent with troublesome dyskinesia in patients experiencing motor fluctuations while on optimised levodopa/carbidopa therapy. Additionally, the onset of improvement of motor fluctuations occurred early in treatment.”
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. so more fully characterize the clinical benefits of Xadago, Zambon will continue to work with our partners on new clinical trials.”
Marketing authorisation 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.