The European Commission has given the green light to Newron Pharmaceuticals of Italy’s Parkinson’s disease drug Xadago.

Xadago (safinamide) has been approved for mid-to late-stage fluctuating patients as add-on therapy to a stable dose of levodopa alone or in combination with other drugs. This is the first time in 10 years that a new chemical entity has received EC approval for PD.

Newron quoted Werner Poewe of Innsbruck Medical University as saying that levodopa is the gold standard but “its long-term use is associated with motor complications which still constitute a major unmet medical need in PD therapy. "Targeting non-dopaminergic systems might be an alternative approach to improve and control such motor complications, enhancing efficacy and removing the need for further increases in levodopa dose”.

Xadago will be marketed by fellow Italian firm Zambon.