Af­ter an odyssey of set­backs, FDA fi­nal­ly green-lights Newron’s Parkin­son’s drug Xada­go

For Italy’s Newron, per­sis­tence has fi­nal­ly paid off. Af­ter fol­low­ing two rad­i­cal­ly dif­fer­ent paths to get its add-on ther­a­py sa­fi­namide on the mar­ket in Eu­rope and the US, the FDA has fi­nal­ly of­fered a green light for their Parkin­son’s drug sa­fi­namide af­ter sev­en years of tri­al and er­ror.

While the com­pa­ny sub­mit­ted an MAA in Eu­rope in 2013, set­ting them on a path to ap­proval on the con­ti­nent in ear­ly 2015, the FDA re­fused to even ac­cept their first ap­pli­ca­tion in 2014, fault­ing them for a se­ries of mis­takes in the NDA. A re­jec­tion fol­lowed their first ac­cept­ed fil­ing, with con­cerns about po­ten­tial abuse of the drug that need­ed to be ad­dressed first.

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