Newron is becoming a leader in the development of innovative therapies for Central Nervous System (CNS) disorders and pain and is committed to improving the quality of life of patients around the world. Our team has a proven track record of bringing drugs to market in these areas and has built a well-balanced pipeline that embodies highly innovative compounds at different stages of development. Our search and development resources are focused on delivering novel therapies for rare CNS diseases.
Following the positive CHMP opinion in December 2014, the EU Commission approved Xadago® (safinamide) for mid-late stage PD patients on Februray 2015.
An MAA has been submitted to Swissmedic in March, 2014, by Zambon and obtained the approval for use in Parkinson’s disease in November 2015.
The New Drug Application (NDA) to the U.S. FDA has been accepted for filing in early March 2015, after being re-submitted by Newron on Dec. 26, 2014.
Newron is working towards global approval of the compound, together with its partners.