FDA signs off on Parkinson's add-on drug Xadago

The FDA on Tuesday approved Newron Pharmaceuticals' Xadago.

An add-on Parkinson’s med already available in various countries in Europe will soon make its way to the U.S. as the FDA on Tuesday approved Newron Pharmaceuticals’ Xadago.

Xadago earned the FDA thumbs-up as a complementary treatment for patients who are on levodopa/carbidopa. It’s designed for use when patients experience an “off” episode, or a period when their primary drugs stop working as well, and has shown in trials to increase “on” time when symptoms are reduced, according to a release.

The approval comes one year after Zambon, which owns commercial rights to Xadago outside of Asia, teamed up with US WorldMeds to bring the drug to the U.S. Through that deal, US WorldMeds agreed to pay upfront, regulatory and commercial milestone payments. It’s also set to pay future royalties.

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The drug could reach peak sales of $500 million, Newron has said.

Xadago failed a phase 3 trial back in 2010 and suffered a previous FDA rejection last March. That trial failure was one in a series of setbacks for the company, including a cancelled partnership with German Merck, a CEO departure and a retracted $63 million purchase offer from Biotie.

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In September last year, Newron resubmitted its med after the FDA agreed that no new data were required for the review. The regulator originally worried about the drug’s abuse potential.

According to a release (PDF) from Newron, Xadago is the first new Parkinson’s drug approved by the FDA in more than a decade. An estimated 1 million Parkinson’s patients live in the U.S., according to the National Institutes of Health.

In a statement, C. Warren Olanow of the Mount Sinai School of Medicine said the medicine in trials “provided a significant reduction in OFF time and a significant increase in ON time without troublesome dyskinesia,” or difficulty moving that can occur as a side effect to long-term treatment with levodopa.