Eisai and Meiji's Novel Selective MAO-B Inhibitor Equfina (Safinamide) Approved in South Korea for Parkinson’s Disease

June 27, 2020 News /BioValleyBIOON/ -- Japanese pharmaceutical company Eisai recently announced that the Ministry of Food and Drug Safety (MFDS) of South Korea has approved its new Parkinson’s disease drug, Equfina (safinamide), as an adjunct therapy to levodopa-containing products for the treatment of patients with idiopathic Parkinson’s disease experiencing end-of-dose motor fluctuations.

In South Korea, Eisai’s subsidiary, Eisai Korea, submitted a marketing authorization application for safinamide in July 2019. With this approval, South Korea has become the first country in Asia, aside from Japan, to approve safinamide for market launch.

In Japan, Equfina was approved in September 2019 for improving wearing-off phenomena in patients with Parkinson’s disease who are being treated with a levodopa-containing medication.

Pursuant to the licensing agreement signed in March 2017 between Eisai and Meiji Seika Pharma Co., Ltd. (“Meiji”), Eisai obtained exclusive marketing rights for safinamide in Japan, as well as development and marketing rights 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 on the U.S. market in over a decade. Furthermore, safinamide has also been approved for marketing in more than ten European countries. In both the U.S. and European markets, safinamide is marketed under the brand name Xadago. It is recommended for use in combination with levodopa or other Parkinson’s disease medications for the treatment of mid-to-late stage idiopathic Parkinson’s disease.

Parkinson’s disease (PD): After a certain period of pharmacological treatment, therapeutic efficacy may decline and long-term adverse effects may emerge, such as motor fluctuations (including wearing-off and on-off phenomena). The wearing-off phenomenon refers to the recurrence or exacerbation of PD motor and non-motor symptoms that occur before the next dose and are promptly relieved after medication administration.

Equfina was approved in South Korea primarily based on a double-blind, placebo-controlled, Phase III study (the SETTLE study). Conducted across multiple countries (including South Korea), this study evaluated the efficacy and safety of once-daily oral safinamide as an adjunct to levodopa over a 24-week treatment period in patients with Parkinson’s disease experiencing motor fluctuations. The primary endpoint was the change from baseline to week 24 in mean daily non-disabled time (“ON-time,” defined as the period during which Parkinsonian symptoms are controlled).

Data showed that patients treated with safinamide had an increase in ON-Time of 0.96 hours compared to those receiving placebo (95% CI: 0.56, 1.37; p < 0.001), demonstrating a statistically significant prolongation of ON-Time. In the study, the three most commonly observedAdverse ReactionsDyskinesia, nausea, and somnolence.

Parkinson's disease (PD) is a neurodegenerative disorder that can cause motor impairments, including tremors in the limbs, muscle rigidity, and gait disturbances. The disease is caused by the degeneration of the dopaminergic system, leading to a deficiency of the neurotransmitter dopamine in the brain.

Levodopa is currently the most effective and widely used medication for the treatment of Parkinson’s disease, with up to 75% of patients taking this drug. Levodopa effectively replenishes dopamine levels in the brain; however, as the disease progresses, the duration of its therapeutic effect (i.e., ON-time) gradually shortens. In some patients, Parkinsonian symptoms reemerge before the next dose of levodopa is administered, a phenomenon known as “wearing-off.” To prevent the occurrence of wearing-off, levodopa is often combined with other medications that have different mechanisms of action.

The active pharmaceutical ingredient of Equfina is safinamide, a novel selective monoamine oxidase B (MAO-B) inhibitor that reduces the degradation of secreted dopamine, helping to maintain dopamine levels in the brain. Additionally, safinamide blocks voltage-dependent sodium channels on neurons, thereby inhibiting glutamate release. Thus, this medication represents a novel therapeutic agent for Parkinson’s disease with both dopaminergic and non-dopaminergic mechanisms. Several previously conducted global clinical studies have demonstrated that safinamide, when used in combination with levodopa for the treatment of mid-to-late stage Parkinson’s disease, can prolong ON-time and improve motor function.

Safinamide was discovered and developed by the Italian pharmaceutical company Newron. In 2011, Meiji entered into a licensing agreement with Newron, obtaining exclusive rights to develop, manufacture, and market safinamide in Japan and other Asian countries. In March 2017, Eisai partnered with Meiji Seika Pharma to acquire exclusive rights to safinamide in Japan and other Asian countries. (Bioon.com)

Original Source: EISAI RECEIVESappROVAL FOR PARKINSON’S DISEASE TREATMENT EQUFINA® IN SOUTH KOREA