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FDA approves Newron's Parkinson's disease drug Xadago

Becomes first new treatment licensed for the condition in over a decade

US Food and Drug Administration (FDA)

US regulators have licensed the first new treatment in over a decade for Parkinson’s disease patients with motor fluctuations.

Newron Pharmaceuticals’ Xadago (safinamide) was approved as an add-on treatment for patients already on levodopa/carbidopa and who experience ‘off’ episodes when those medications don’t work well.

The Italian firm’s chief medical officer Ravi Anand said: “International, randomised, clinical trials have demonstrated that Xadago significantly improves ‘on’ time, ‘off’ time, and Parkinsonism compared to standard of care without increasing time spent with troublesome dyskinesia in patients experiencing motor fluctuations while on optimised levodopa/carbidopa therapy.”

Its approval came on the back of a trial of 645 patients on levodopa and experiencing ‘off’ time. Those on Xadago experienced more beneficial “on” time, when their symptoms were reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo.

The FDA also considered a trial of 549 patients with Parkinson’s disease, where those adding Xadago to their levodopa treatment had more “on” time without uncontrolled involuntary movement compared to those on placebo, and better scores on a motor function assessment during ‘on’ time.

Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said: “Parkinson’s is a relentless disease without a cure. We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

The FDA had previously declined to approve the drug last year, calling for more information on its abuse potential, and in licensing it has placed some restrictions on the drug’s use. It says several types of patients should not be prescribed it, including those with severe liver problems, or those taking the cough medicine dextromethorphan.

Newron has divided up the commercial rights to Xadago, with Italy’s Zambon developing and commercialising the drug in most global markets. The exceptions are Japan and a handful of other territories, and the US, where Meiji Seika and US WorldMeds respectively hold rights to it.

Approved by the European Commission in February 2015 and by Swissmedic later that year, Zambon has so far launched the treatment in 10 European marketing, including Germany, the UK, Spain and Italy.

Article by
Dominic Tyer

22nd March 2017

From: Regulatory

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