Parkinson's new drug! Equfina (safinamide), a new selective MAO-B inhibitor, was approved in Japan!

21 / 09 / 2019 / Biovalley BIOON/-- Eisai and Meiji Seika Pharma (Meiji) recently announced that the new Parkinson's disease drug equfina tablet (safinamide, safinamide) has been approved in Japan for the treatment of Parkinson's disease patients who are receiving a drug containing levodopa to improve the phenomenon of diminishing efficacy Meiji has the production and sales license of safinamide, and Weicai exclusively sells safinamide In the United States, safinamide was approved in March 2017, becoming the first new chemical entity (NCE) approved for Parkinson's disease treatment in the U.S market in more than a decade In addition, safinamide has been approved for sale in more than ten European countries In the U.S and European markets, the brand name of safinamide is xadago, which is recommended to be used in combination with levodopa or other Parkinson's disease drugs for the treatment of idiopathic Parkinson's disease in the middle and late stage This Japanese approval is based on data from a phase II / III clinical study conducted in patients with Parkinson's disease in Japan This study is a multicenter, double-blind, placebo-controlled, randomized, parallel group study At present, it is being treated with L-dopa, but there is a phenomenon of diminishing off effect Two doses of safinamide (50mg and 100mg once a day for 24 weeks) were evaluated as an additional oral therapy The primary end point of the study was the change in mean daily on time from baseline to 24 weeks of treatment On time refers to the time when patients with Parkinson's disease take levodopa for continuous optimal effect and no movement disorder The results showed that, compared with placebo group, the two doses of safinamide treatment group (50mg and 100mg) showed a statistically significant increase in on time In terms of safety, the four most common adverse events in safinamide group were nasopharyngitis, dyskinesia, fall and contusion Parkinson's disease (PD) is a neurodegenerative disease that can cause motor disorders, including limb tremor, muscle stiffness, and gait disorders The disease is caused by the degeneration of the dopamine nervous system, which leads to the lack of the neurotransmitter dopamine in the brain According to Weicai's internal estimates, there are about 300000 Parkinson's patients in Asia (excluding China and India) According to the data of the Ministry of health, labor and welfare (MHLW), there were about 163000 Parkinson's patients in Japan in 2014 In recent years, with the aging of the population, the number is steadily increasing Levodopa is the most effective and widely used drug in the treatment of Parkinson's disease The proportion of patients taking levodopa is as high as 75% Levodopa can effectively supplement the dopamine supply of the brain, but with the development of the disease, the duration of the effect of levodopa (i.e on time) will gradually shorten In some patients, Parkinson's symptoms will appear before the next dose of levodopa treatment, which is the so-called "declining off" phenomenon In order to prevent the phenomenon of wearing off, it is often necessary to combine L-dopamine with other drugs with different mechanisms of action Safinamide is a new selective monoamine oxidase B (MAO-B) inhibitor, which can reduce the degradation of dopamine and help maintain the concentration of dopamine in the brain In addition, safinamide can also block voltage-dependent sodium channels on neurons, thus inhibiting the release of glutamate Therefore, safinamide is a novel Parkinson's disease treatment drug with both dopaminergic and non dopaminergic mechanisms Several previous global clinical studies have shown that safinamide combined with levodopa can prolong on-time and improve motor function in the treatment of advanced Parkinson's disease Safinamide was discovered and developed by Italian pharmaceutical company newron Meiji signed a license agreement with newron in 2011, and obtained the exclusive right to develop, produce and sell safinamide in Japan and other Asian countries In March 2017, Wei Cai reached the cooperation with Meiji essence, and obtained the exclusive right of safinamide in Japan and Asian countries Original source: Eisai and Meiji announce Parkinson's separate treatment equifina ® tables (safinamid mesilate) approved in Japan