Eisai Co. Ltd., based in Tokyo, recently withdrew the company’s new drug application for its ultra-high dose mecobalamin (E0302), which was designed to treat amyotrophic lateral sclerosis (ALS) patients living in Japan.
In May 2015, the company first submitted its new drug application. After several meetings that involved the Pharmaceuticals and Medical Devices Agency (PMDA), officials decided that the application package was not enough to be approved -- which is why Eisai withdrew the application.
In the future, Eisai will be careful to evaluate its development strategy for the new drug. First, the researchers will consult the nation’s regulatory authority.
ALS is a progressive, intractable, neurodegenerative disease that weakens and atrophies the muscles throughout the body. As of today, there are very limited treatment options for ALS patients, making it a serious illness that has unmet medical needs, afflicting people around the world.
Eisai sees neurology as a potential therapeutic answer. The company intends to focus on this area of research and is dedicated to discovering new drugs and developing them within this field. Its goal is to fulfill the unmet medical needs among the patients, particularly in neurology, serving ALS patients and their families around the world.