Xadago refiled with FDA for Parkinsons-Newron Pharma

Newron Pharmaceuticals has announced that the NDA for Xadago (safinamide) has been re-submitted to the 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 first submission of safinamide to the FDA was made in May 2014. On review, the FDA issued a Refusal to File letter based on organizational and navigational problems, largely due relating to the hyperlinking of tables, folders and the organization of the table of contents in the submission. This follows the announcement last week that the CHMP has given a positive opinion on safinamide for Europe.