EMA again rejects Kyowa Kirin's MA for istradefylline for 'OFF' episodes in Parkinson's

15 November 2021

Japanese mid-sized pharma company Kyowa Kirin (TYO: 4151) today announced that, following a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations.

Parkinson’s is a chronic, progressive neurodegenerative condition that affects small regions in the brain that control movement, balance and posture. It is the fastest growing neurodegenerative disorder in the world.

This is a second EMA rejection for istradefylline, trade named Nouryant, as the CHMP in July this year adopted a negative opinion as a medicine to treat adults with Parkinson’s disease. It was approved in the USA under the trade name Nourianz in 2019 and was launched in Japan in 2013.

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