FDA approves Newron’s drug as add-on therapy for Parkinson’s

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By Reuters Staff

<span class="articleLocation”>Newron Pharmaceuticals SpA said on Tuesday the
U.S. Food and Drug Administration approved its Parkinson’s
disease treatment Xadago (safinamide) as an add-on therapy to
levodopa.

In clinical trials, Xadago added to levodopa/carbidopa
provided a significant reduction in “off” time and a significant
increase in “on” time without troublesome dyskinesia in PD
patients experiencing motor fluctuations, the company notes in a
news release.

Xadago received European approval in 2015, and has been
launched by Newron’s parnter Zambon SpA in several countries
including Germany, Italy Spaion and UK.

The FDA rejected Xadago last year, but later said Newron was
not required to perform any studies to evaluate the safety
profile of the drug.

Parkinson’s disease is the second-most common chronic
progressive neurodegenerative disorder in the elderly after
Alzheimer’s disease. Parkinson’s affects an estimated 7-10
million patients worldwide, of whom 1 million are in the United
States.



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