Eisai to Take over Manufacturing and Marketing Approval for Equfina 50mg Tabs from Meiji Seika

TOKYO: (JCN Newswire) – Eisai Co., Ltd. announced today that it will take over by transfer the manufacturing and marketing approval of Parkinson’s disease treatment Equfina 50mg TABLETS (safinamide mesilate, “Equfina”) in Japan from Meiji Seika Pharma Co., Ltd., effective September 23, 2020.

In Japan, Meiji conducted clinical studies of Equfina and obtained its manufacturing and marketing approval in September 2019. Eisai has exclusively sold Equfina in Japan as a distributor. Based on the license agreement signed between Eisai and Meiji, Eisai will take over by transfer the manufacturing and marketing approval of Equfina from Meiji. Eisai, as the manufacturer and distributor of Equfina in Japan, will continue to provide information on the proper usage of Equfina.

Equfina, developed by Meiji in Japan, is a once-daily oral treatment for Parkinson’s disease. It is a selective and reversible monoamine oxidase B (MAO-B) inhibitor that helps to maintain the density of endogenous dopamine and exogenous dopamine from levodopa-containing drugs in the brain (dopaminergic mechanism). In addition, Equfina blocks voltage-dependent sodium ion channels and inhibits glutamate release (non-dopaminergic mechanism). In the clinical studies conducted in Japan for Parkinson’s disease patients under treatment with a drug containing levodopa, the extension of levodopa’s duration of effect (“on” time) of one hour or more and improvement of motor functions were shown. Improvement effect on the wearing off phenomenon is expected.

Following the completion of the transfer, Eisai will continue to deliver Equfina, a new option for Parkinson’s disease treatment in Japan to patients, thereby increasing the amount of time that they can freely engage in activities on their own initiative. Eisai will further contribute to improving the QOL of patients and enabling their families to create a vibrant daily life.