Eisai gains South Korean approval for Equfina

Japanese pharma major Eisai (TYO: 4523) has received marketing approval of Equfina (safinamide mesylate) for treatment of idiopathic Parkinson’s disease as adjunctive therapy with levodopa-containing products in patients with end of dose motor fluctuations from South Korea’s Ministry of Food and Drug Safety).

The marketing authorization application for safinamide in South Korea was submitted in July 2019, and through the approval of this application, South Korea became the first country in Asia outside of Japan to grant marketing clearance for safinamide.

This approval is primarily based on a double-blind, placebo-controlled, Phase III study (SETTLE study) in overseas countries, including South Korea, to evaluate the efficacy and safety of 24-week oral administration of the once-daily safinamide as an add-on to levodopa in patients with Parkinson’s disease with motor fluctuations.1