New Parkinson's therapy approved by the FDA

Last updated: 01 November 2019

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This is a summary of an article on Endpoint News


Japanese pharma group, Kyowa Hakko Kirin, won FDA approval for a Parkinson’s disease medicine, istradefylline, branded as Nourianz. The medicine is approved as an add-on to the first-line treatment levodopa/carbidopa.

Nourianz (istradefylline) is reported to play a role in controlling voluntary movement. The medicine won approval based on four 12-week placebo-controlled clinical studies with 1,143 participants. Patients showed a statistically significant decrease in 'off episodes' (the amount of time when the first-line medicines are not working well) from baseline compared to placebo.


Source
Natalie Grover. Decades in the making, Kyowa Hakko Kirin finally wins FDA approval for add-on Parkinson's therapy. Endpoint News. 28/08/2019.