Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency

Dylan Macdonaldblog

Tokyo, Japan, January 6th , 2020 — Kyowa Kirin Co., Ltd. (TSE: 4151 President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announces that its marketing authorisation application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson’s disease (PD) experiencing “OFF” time, has been validated by the European Medicines Agency (EMA) and is now under review.

This MAA is based on findings from randomised, multi-national, including EU, US and Japan double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa-based regimens  with or without other PD medications.

“Parkinson’s disease is the fastest growing neurological disorder in the world in terms of prevalence, disability and deaths1,” said Abdul Mullick, President, Kyowa Kirin International (Europe, Middle East and Africa (EMEA)). “There is significant need for new treatments for this debilitating condition. We are very excited about the possibility of bringing a new medicine to patients that works in a different way from current therapies. We look forward to working with the EMA during the review process.”

“I welcome the news of this validation, enabling the EMA to begin the review process,” said Tomohiro Sudo, Head of Global Product Management Office, Kyowa Kirin, “We are committed to providing this innovative medicine as a new treatment option for Parkinson’s disease patients who need more treatments to improve their situation. We will keep making our best efforts to improve the lives of patients in the European Union.”

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Download the full press release here.