Kyowa Kirin provides update on application for istradefylline in Europe for the treatment of ‘OFF’ episodes in people livingwith Parkinson’s

Kyowa Kirin Co., Ltd. has announced that the European Medicines Agency’s (EMA) 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. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson’s and are currently reviewing the options available, which may include re-examination.

Abdul Mullick, President of Kyowa Kirin International stated: “There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson’s, and we believe that istradefylline offers people living with the condition a chance to regain some control over the management of their ‘OFF’ time. We remain committed to pursuing the registration of istradefylline in the EU.”

“Parkinson’s is a complex condition that affects every person living with it differently and is characterised by a broad range of symptoms that can significantly impact their quality of life,” said Professor Heinz Reichmann, Professor and Chair of the Neurology Department at the University of Dresden. “There is currently an urgent need for innovative treatments such as istradefylline for people living with Parkinson’s, to support them and their families in reducing their ‘OFF’ time. I hope that the CHMP will reconsider their position on istradefylline.”