Newron on track to seek approval for safinamide in H2 2013.
The company seeks authorisation of the drug as add-on therapy for the treatment of both early (non-fluctuating) and advanced (fluctuating) patients with idiopathic PD.
Newron said that it has recently met with European health regulators to discuss the data from the preclinical, CMC, and clinical studies to support registration of safinamide. The authorities have agreed with the adequacy of the safinamide programme for preclinical toxicology, CMC, DMPK, and the size of the clinical safety data base that will be part of the submission. The company has also received feedback about the findings of the studies showing statistically significant efficacy of safinamide as add-on therapy in patients receiving a stable dose of a single dopamine agonist in early PD patients and on motor fluctuations in patients with advanced PD on levodopa and other PD treatments.
Safinamide is being co-developed by Newron together with its local partner Zambon Pharma and its Japanese collaborator Meiji Seika Pharma.
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|Date:||Nov 14, 2012|
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