25. Nourianz

Kyowa Kirin manufacturing plant
(Kyowa Kirin)

Active ingredient: istradefylline
Disease: Parkinson’s disease
Peak sales estimate: n/a
Approved: Aug. 27, 2019
Company: Kyowa Kirin

The scoop: Kyowa Kirin won FDA approval for istradefylline as an add-on treatment for Parkinson’s disease in August, more than 10 years after it was handed a thumbs-down in 2008 and six years after it got its Japanese go-ahead. The drug, branded as Nourianz, is designed to help patients during “off” episodes, when their medications are not working well enough at controlling symptoms. It targets the adenosine A2A receptor in the brain’s basal ganglia. Other drugs of that mechanism, including ones from Merck & Co., a partnership between Vernalis and Biogen, and Acord Therapeutics, had racked up failures. The FDA based its decision on results from four clinical studies, where patients who got Nourianz experienced significant decreases in daily “off” time. However, in another phase 3 trial, the drug only showed a favorable trend that didn’t cross the statistics bar. The Japanese pharma also has another similar drug dubbed KW-6356 in the works. — Angus Liu

25. Nourianz

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