Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area with a long experience in respiratory disease therapies, woman care and primary care, announce that the New Drug Application (NDA) for safinamide was submitted today to the US Food and Drug Administration (FDA).
The submission covers the indications "safinamide as add-on therapy to a stable dose of a single dopamine agonist" in early Parkinson's disease patients and "safinamide as add-on therapy to levodopa alone or in combination with other Parkinson's disease treatments" in mid-to late stage Parkinson's disease patients. The submission was based on completion of activities agreed upon during meetings with the FDA.
The submission was made by Newron, which is the NDA holder until completion of the sublicense process for the US rights to safinamide, by Zambon.
Stefan Weber, Newron's CEO, commented: "We are both proud and excited to be submitting the Company's first ever NDA, for safinamide. Parkinson's disease is a debilitating condition and this brings us one crucial step closer to providing an innovative treatment to improve the quality of life for these patients."
Ravi Anand, Newron's CMO, commented: "Following the usual review periods, we are optimistic that safinamide will receive approval within Europe by end of this year, and in the US within 12 months. After submission of the filings in the European Union, the US and Switzerland, we will now support filings in additional territories based on the US and EU documentation, as planned by our partners."
Maurizio Castorina, Zambon Pharma CEO, stated: "Zambon is strongly committed to preparing the launch of safinamide in territories core to its strategy, and to advancing and completing the licensing process for additional territories, including the US. We are convinced that safinamide will bring benefits to both patients and Health Authorities alike."
Marco Sardina, Zambon Pharma CSO, added: "There is still a strong medical need for new, safer therapies to effectively treat motor symptoms and motor complications of Parkinson's disease patients. Zambon and its sublicencees will take the actions required to fully exploit the innovative therapeutic potential of safinamide."