EMA Says No to Nouryant for Marketing Approval in Europe

EMA Says No to Nouryant for Marketing Approval in Europe

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EMA Says No to Nouryant for Marketing Approval in Europe

A committee of the European Medicines Agency (EMA) is recommending the refusal of marketing authorization for Nouryant (istradefylline) — approved as Nourianz in the U.S. — as a medication for treating off episodes in Parkinson’s disease in the EU. In its opinion, the Committee for Medicinal Products for Human Use, known as CHMP, said the benefits of Nouryant may not outweigh its risks. It recommended the refusal of an application by Kyowa Kirin, the therapy’s developer,…

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