Pharma Focus Asia

Newron Pharmaceuticals: Commercialization Partner Meiji Seika Together with Eisai Announce the Approval of Safinamide for Parkinson’s Disease in Japan

Monday, September 23, 2019

Newron Pharmaceuticals S.pA., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, is pleased to note its partner Meiji Seika Pharma Co., Ltd., together with Eisai Co., Ltd., have announced the manufacturing and marketing approval in Japan for Equfina® TABLETS (safinamide mesilate, “safinamide”) for the indication of improvement of wearing-off phenomenon in patients with Parkinson’s disease under treatment with a drug containing levodopa.

The full text of the announcement from Meiji Seika and Eisai is as follows:

Eisai and Meiji Announce Parkinson’s Disease Treatment Equfina® TABLETS (Safinamide Mesilate) Approved in Japan

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Meiji Seika Pharma Co., Ltd. (Headqurters: Tokyo, CEO: Daikichiro Kobayashi, “Meiji”) today announced the manufacturing and marketing approval in Japan for the indication of improvement of wearing-off phenomenon in patients with Parkinson’s disease under treatment with a drug containing levodopa for Equfina® TABLETS (safinamide mesilate, “safinamide”), which was developed for use in the treatment of patients with Parkinson’s disease, was obtained. In Japan, Meiji holds the manufacturing and marketing approval for safinamide, and Eisai exclusively sells safinamide.

Parkinson’s disease is a neurodegenerative disease which causes motor impairment, with symptoms including tremors in the limbs, muscular rigidity and shuffling gait. It is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. There are approximately 200,000 patients suffering from Parkinson’s disease in Japan, and the number of patients is increasing due to the aging of the population. Drugs containing levodopa are widely used to treat Parkinson’s disease by replenishing the brain’s supply of dopamine. However, as the disease progresses, levodopa’s duration of effect (“on” time) decreases, and there are cases where patients may experience wearing-off phenomena, a return of Parkinson’s disease symptoms before the next dose. Safinamide through its main mechanism of action as a selective monoamine oxidase B (MAO-B) inhibitor, increases the density of endogenous dopamine and exogenous dopamine from levodopa-containing drugs in the brain.

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

In study ME2125-3, the change in mean daily “on” time from baseline to 24 weeks of the treatment phase, which is the primary endpoint, of treatment with safinamide 50 mg and 100 mg were statistically significant compared to placebo-controlled treatment. The most common adverse drug reactions (ADRs) (incidence 3% and higher) observed with patients with safinamide 50 mg and 100 mg were dyskinesia and visual hallucination. Also, in study ME2125-4, with regard to the change in mean daily “on” time from baseline to 52 weeks of the treatment phase, the “on” time with long-term administration of safinamide was extended, and showed the continued effectiveness. The most common ADRs (incidence 3% and higher) observed with patients were dyskinesia, falls, and constipation.

By providing Equifina TABLETS as a new option for Parkinson’s disease treatment, Eisai and Meiji will make further contributions to address the diverse needs of, and increase the benefits provided to, Parkinson’s disease patients and their families.

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