Newron and Zambon re-submit NDA for safinamide following Refusal to File

Clinical-stage biopharma company Newron (NWRN: SIX) and its commercial development partner, fellow Italy-based pharma company Zambon, have re-submitted their New Drug Application for safinamide to the US Food and Drug Administration.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has already given a positive opinion on the drug for Europe. The NDA submission covers safinamide as an add-on therapy to a stable dose of a single dopamine agonist in early Parkinson’s disease patients. It is also submitting for mid-to-late-stage Parkinson’s as an add-on therapy to levodopa alone or in combination with other treatments for the disease.

The first submission was made to the FDA in May 2014, to which the FDA issued a Refusal to File letter due to organizational and navigational problems because of hyperlinking of tables, folders and the way the table of contents in the submission was organized.