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

, 27 June 2020 /PRNewswireBiovalleyBIOON/-- Eisai, a Japanese pharmaceutical company, recently announced that the Korea Food and Drug Administration (MFDS) has approved its new Parkinson's drug Equfina (safinamide, saffinamide), as an auxiliary treatment containing lvodopa products, to treat patients with endemic Parkinson's disease with end-of-course fluctuations (dose motor)in Korea, Eisai Korea, a subsidiary of Thesio, filed a marketing authorization application for safinamide in July 2019, with which South Korea became the first country in Asia outside Japan to approve the listing of safinamidein Japan, Equfina was approved in September 2019 for use in patients with Parkinson's disease who are undergoing a treatment with a dopa drug containing lvocycloUnder the license agreement signed in March 2017 between Aishi and Meiji Seika PharmaceuticalCoA, Aishi obtained exclusive sales rights to safinamide in Japan, as well as development and sales rights in Asiain the United States, safinamide was approved in March 2017, the first new chemical entity (NCE) approved for the treatment of Parkinson's disease in the U.Smarket in more than a decadeIn addition, safinamide has been approved for sale in more than a dozen European countriesIn the U.Sand European markets, safinamide, whose brand name is Xadago, is recommended in combination with levodopa or other Parkinson's drugs for the treatment of ireal Parkinson'streatment of Parkinson's disease (PD) for a certain period of time will result in reduced efficacy and long-term side effects, such as movement fluctuations (including end of the agent, switch, etc.)The end of the agent phenomenon refers to the recurrence or exacerbation of PD movement and non-motor symptoms that appear before taking the drug and can be alleviated after taking the drugEqufina was approved in Korea, based primarily on a double-blind, placebo-controlled, Phase III study (SETTLE study)The study, conducted in several countries,including South Korea, assessed the efficacy and safety of once daily oral safinamide as an adjunct drug for 24 weeks in patients with developed Parkinson's disease with movement fluctuationsIn the study, the main endpoint was the change in the average daily non-deactivation time (ON-Time, the period during which Parkinson's symptoms were suppressed) from baseline to 24-week treatmentdata showed that patients treated with safinamide increased ON-Time by 0.96 hours (95% CI: 0.56, 1.37; p 0.001) compared to placebo patients, showing a statistically significant increase in ON-TimeThe three most commonadverse reactions observed in the studywere movement disorders, nausea and drowsinessParkinson's disease (PD) is a neurodegenerative disease that can cause movement disorders, including limb jitter, muscle stiffness and gait disordersThe disease is caused by the degeneration of the dopamine nervous system, which leads to a lack of dopamine, the neurotransmitter in the brainlevodopa is the most effective and widely used drug for Parkinson's, with a 75% dose of the drug taken in patient stakesL-dopahla can effectively replenish the brain's dopamine supply, but as the disease develops, the duration of the treatment of levodopamine (i.e., ON-Time) will gradually shorten, and in some patients Parkinson's symptoms will appear before the next dose of Ldopamine treatment, known as "wearing-off"In order to prevent the emergence of the wearing-off phenomenon, it is often necessary to combine l-dopamine with other drugs with different mechanisms of actionEqufina's active drug ingredient is safinamide, a new selective monoamine oxidase B (MAO-B) inhibitor that reduces the degradation of dopamine that has been secreted and helps maintain dopamine concentrations in the brainIn addition, safinamide can also block the voltage-dependent sodium ion channels on neurons, thereby inhibiting the release of glutamate, so the drug is a novel treatment for Parkinson's disease with both dopamine and non-dopamine energy mechanismsSeveral previous global clinical studies have shown that safinamide combined with lvocyclodopa to treat advanced Parkinson's disease can extend ON-Time and improve motor functionsafinamide was discovered and developed by Italian pharmaceutical company NewronMeiji entered into an authorization agreement with Newron in 2011 and acquired the exclusive rights to the development, production and sale of safinamide in Japan and other Asian countriesIn March 2017, Theisse entered into a partnership with Meiji Essence, acquiring the exclusive rights to safinamide in Japan and other Asian countries(BioValleyBioon.com)original source: EISA RECEIVES app
ROVAL FOR PARKINSON'S DISEASE TREATMENT EQUFINA® IN SOUTH KOREA .