Eisai withdraws application for neurodegenerative-disease drug in Japan
pharmafile | March 22, 2016 | News story | Manufacturing and Production, Research and Development | Eisai, mecobalamin, neurodegenerative disease
Pharma major Eisai (TYO: 4523) on Tuesday said the Japanese regulators have stalled the approval of its drug to treat a neurodegenerative disease, citing insufficient information.
As a result the company has withdrawn its new drug application for mecobalamin, in Japan, following a meeting with the Pharmaceuticals and Medical Devices Agency (PMDA). Eisai said it will “carefully reconsider the future development strategy” for mecobalamin after consultation with the regulatory authority.
In May last year, Eisai filed for regulatory approval for mecobalamin as a treatment for amyotrophic lateral sclerosis (ALS).
ALS is an intractable, progressive, neurodegenerative disease that causes severe muscle atrophy and weakness in the muscles. Currently, there are limited treatment options for the disorder.
As the main cause of death is respiratory failure due to paralysis of the respiratory muscles, without the use of an artificial respirator, death occurs within about 3 and 6 years from the onset of the disease. In Japan, the incidence rate of ALS ranges between 1.1 to 2.5 per 100,000 people, and onset most often occurs between the ages of 50 to 60.
Mecobalamin is approved and marketed as a treatment for peripheral neuropathies and other conditions.
Anjali Shukla
Related Content
Eisai shares new data for Leqembi for Alzheimer’s treatment
Eisai and Biogen have announced that Eisai has shared new data for Leqembi (lecanemab-irmb) 100mg/mL …
FDA grants Alzheimer’s disease drug Leqembi full approval
Japanese pharmaceutical company Eisai and US-based biotechnology company Biogen have announced that the US Food …
Eisai and Wren Therapeutics join forces to tackle neurodegenerative synucleinopathies
Eisai has forged an exclusive research partnership with Wren Therapeutics to develop new approaches in …