Eisai/Meiji's New Selective MAO-B Inhibitor Equfina (safinamide) Was Approved In Korea!

- Jul 10, 2020-

Japanese pharmaceutical company Eisai recently announced that the Korea Food and Drug Administration (MFDS) has approved its new Parkinson's disease drug Equfina (safinamide) as an adjuvant therapy containing levodopa products for the treatment of end-dose movement fluctuations (Dose motor fluctuation) patients with idiopathic Parkinson's disease.


In South Korea, Eisai Korea, a subsidiary of Eisai, submitted a marketing authorization application for safinamide in July 2019. With this approval, South Korea became the first country in Asia to appoint safinamide to go public except Japan.


In Japan, Equfina was approved in September 2019 for patients with Parkinson's disease who are receiving a drug containing levodopa to improve the wearing-off phenomenon.


According to the license agreement signed between Eisai and Meiji Seika Pharma ("Meiji") in March 2017, Eisai obtained the exclusive right to sell safinamide in Japan and the right to develop and sell in Asia .


In the United States, safinamide was approved in March 2017, becoming the first new chemical entity (NCE) approved for the treatment of Parkinson's disease in the US market in more than a decade. In addition, safinamide has also been approved for sale in more than ten European countries. In the US and European markets, the brand name of safinamide is Xadago. The drug is recommended to be combined with levodopa or other Parkinson's disease drugs for the treatment of idiopathic Parkinson's disease.


Parkinson's disease (PD) drug therapy will show a decrease in efficacy and long-term side effects after a certain period of time, such as movement fluctuations (including end-of-agent, switch, etc.). The end-of-dose phenomenon refers to the reappearance or aggravation of PD exercise and non-exercise symptoms that appear before the medication and can be relieved after the medication.


Equfina was approved in Korea, mainly based on a double-blind, placebo-controlled, phase III study (SETTLE study). This study was conducted in several countries (including South Korea) to evaluate the efficacy and safety of safinamide once daily as an adjunct to levodopa for Parkinson's disease patients with movement fluctuations for 24 weeks. In this study, the primary endpoint was the change in the average daily non-disability time (ON-Time, the time period during which Parkinson's symptoms were suppressed) from baseline to the 24-week treatment period.


The data showed that patients treated with safinamide had an ON-Time increase of 0.96 hours (95%CI: 0.56, 1.37; p<0.001) compared with placebo patients, showing that ON-Time was statistically significantly prolonged. In the study, the three most common adverse reactions observed were dyskinesia, nausea and drowsiness.

safinamide

Parkinson's disease (PD) is a neurodegenerative disease that can cause movement disorders, including limb shaking, muscle stiffness, and gait disorders. The disease is caused by the degeneration of the dopamine nervous system, resulting in a lack of the neurotransmitter dopamine in the brain.


Levodopa is currently the most effective and widely used drug for the treatment of Parkinson's disease. The proportion of patients taking this drug is as high as 75%. L-dopa can effectively supplement the supply of dopamine in the brain, but as the disease progresses, the duration of the effect of L-dopamine (ie, ON-Time) will gradually shorten, and in some patients, Parkinson's symptoms will appear before the next dose of levodopa treatment , The so-called "wearing-off" phenomenon. In order to prevent the appearance of wearing-off phenomenon, it is often necessary to combine levodopa with other drugs with different mechanisms of action.


The active pharmaceutical ingredient of Equfina is safinamide, a new type of selective monoamine oxidase B (MAO-B) inhibitor, which can reduce the degradation of secreted dopamine and help maintain the concentration of dopamine in the brain. In addition, safinamide can also block voltage-dependent sodium channels on neurons, thereby inhibiting the release of glutamate. Therefore, the drug is a novel treatment for Parkinson's disease with both dopaminergic and non-dopaminergic mechanisms. . Several previous global clinical studies have shown that safinamide combined with levodopa in the treatment of advanced Parkinson's disease can prolong ON-Time and improve exercise performance.


Safinamide was discovered and developed by the Italian pharmaceutical company Newron. Meiji signed a licensing agreement with Newron in 2011 and obtained the exclusive right to develop, produce and sell safinamide in Japan and other Asian countries. Eisai reached a cooperation with Meiji Essence in March 2017 and obtained the exclusive rights of safinamide in Japan and other Asian countries.