EU approves Xadago for Parkinsons-Newron Pharma
The European Commission has approved the use of Xadago (safinamide), from Newron Pharmaceuticals, for the treatment of idiopathic Parkinson’s disease. The drug has been approved for mid-to late-stage fluctuating patients as add-on therapy to a stable dose of levodopa (l-dopa) alone or in combination with other Parkinson's disease medicinal products.
The decision follows the positive opinion adopted by the committee for medicinal products for human use on December 18th, 2014 and is applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway. A new drug application for Xadago to the US FDA was resubmitted in December 2014.
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