The European Medicines Agency accepted Kyowa Kirin Co. Ltd.'s Parkinson's treatment istradefylline, or KW-6002, for review.
The Tokyo-based pharmaceutical company is seeking the EMA's approval to use istradefylline, which is known as Nourianz in the U.S., as an additional treatment for Parkinson's patients who are experiencing so-called off periods. These periods occur in patients taking levodopa or levodopa-based regimens, but either do not see any benefit or experience a delay before the medication takes effect.
During off times, Parkinson's symptoms re-emerge and can reach, or are, at their worst. According to an estimate, more than 40% of Parkinson's patients experience off episodes after taking levodopa for four to six years.
Levodopa is one of the main drugs used to treat Parkinson's.
Kyowa Kirin said its application was supported by clinical trials that evaluated the medicine's effectiveness in patients taking levodopa-based treatment regimens, regardless of whether they were taking any additional medications for their condition.