Eisai Withdraws New Drug Application for Ultra-high Dose Mecobalamin for ALS in Japan

Eisai Co. has withdrawn its New Drug Application for ultra-high dose mecobalamin (E0302) for ALS in Japan.  Last May, the company submitted the New Drug Application for the drug, which is a form of the vitamin B12 that is already approved in Japan for treatment of peripheral neuropathies and other indications (see May 2015 news). However, recent meetings with the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), clarified that the current application was insufficient for approval and Eisai subsequently withdrew its application. It is unclear whether the company will continue its development efforts of mecobalamin in ALS.

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