Eisai Co., Ltd announced that Eisai Korea Inc., Eisai’s subsidiary in South Korea, has launched the Parkinson’s disease treatment Equfina® (safinamide mesilate, “safinamide”). This is the first launch of Equfina in the Asian region excluding Japan.
The estimated number of patients with Parkinson’s disease is approximately 150,000 in South Korea. Parkinson’s disease has high unmet medical needs because of inadequate symptom control using current medications, necessitating new treatment options. This disease is designated as a rare intractable disease in South Korea.
The marketing approval of this drug in South Korea is primarily based on a double-blind, placebo-controlled, Phase III Study (SETTLE study) conducted overseas (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.
Under the license agreement signed between Eisai and Meiji Seika Pharma Co., Ltd Eisai, as the manufacturer and distributor, is responsible for distribution of Equfina in Japan. In Asia, Eisai has exclusive rights for development and marketing for safinamide, and is now applying for new drug approval of the drug in Taiwan, while preparing for submission of applications in other countries as well
Currently, the number of patients with Parkinson’s disease in Asia is estimated to be approximately 3 million. With aging of the population, the number of patients is expected to increase year by year. Together with providing Equfina as a new treatment option for Parkinson’s disease to patients in South Korea, Eisai will make further contributions to address the diversified needs of Parkinson’s disease patients and their families in Asia, and increase the benefits provided to them.
