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    Eisai’s Equfina 50mg Tablets (Safinamide Mesilate) Launched in Japan

    Published on November 20, 2019

    TOKYO:  Eisai Co., Ltd. announced today that it has launched the Equfina 50mg TABLETS (safinamide mesilate, “Equfina”) for the indication of improvement of the wearing-off phenomenon in patients with Parkinson’s disease under treatment with a drug containing levodopa in Japan.

    Manufacturing and marketing approval of Equfina were obtained on September 20, 2019, and Equfina was included in Japan’s National Health Insurance Drug Price List on November 19, 2019.

    Equfina, developed by Meiji Seika Pharma Co., Ltd. in Japan, is a once-daily oral treatment for Parkinson’s disease, and is selective and reversible monoamine oxidase B (MAO-B) inhibitor helping 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 Japanese clinical studies for Parkinson’s disease patient 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. The improvement effect of the wearing-off phenomenon is expected.

    This approval is based on a double-blind, placebo-controlled Phase II/III study (study ME2125-3) to evaluate the efficacy and safety of Equfina as add-on therapy as well as an open label Phase III study (study ME2125-4) to evaluate the safety and efficacy of long-term administration of Equfina in Japanese patients with Parkinson’s disease with wearing-off phenomena who are currently receiving levodopa.

    In the study ME2125-3, with regard to the change in mean daily “on” time from baseline to 24 weeks of the treatment phase with Equfina (50 mg and 100 mg), the “on” time showed the statistically significant increases compared to placebo-controlled treatment (50mg of Equfina: 1.39 hours extension (95%CI: 0.67, 2.11, P=0.0002), 100mg of Equfina: 1.66 hours extension (95%CI: 0.93, 2.39, p<0.0001)). The most common adverse drug reactions (ADRs) (incidence 3% and higher) observed with patients with Equfina were dyskinesia and visual hallucination.
    In the study ME2125-4, with regard to the change (Least Square Mean (LSM) +/= Standard Deviation of Lateral Position (SDLP)) in mean daily “on” time from baseline to 52 weeks of the treatment phase, the “on” time with long-term administration of Equfina (50mg and 100mg) was extended (1.42+/=2.72 hours), and showed the continued effectiveness. The most common ADRs (incidence 3% and higher) observed with patients with Equfina were dyskinesia, falls, and constipation.

    There are approximately 200,000 patients suffering from Parkinson’s disease in Japan,(1) and the number of patients is increasing due to the aging of the population.(1),(2) Drugs containing levodopa are widely used to treat Parkinson’s disease by replenishing the brain’s supply of dopamine. However, as the disease progresses, the “on” time decreases, and there are cases where the patients may experience wearing-off phenomenon, a return of Parkinson’s disease symptoms before the next dose. Decrease of “on-time which effects the opportunity for work and daily activities for patients with Parkinson’s disease is a major factor to lower the quality of life (QOL).

    In Japan, Meiji holds the manufacturing and marketing approval for Equfina, and Eisai exclusively sells Equfina. With providing Equfina as a new option for Parkinson’s disease treatment in Japan, Eisai will make further contribution to improve the patients’ QOL and to create the daily energetic lives of patients’ families, by increasing the time that Parkinson’s disease patients can freely be active on their own will.

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