Eisai seeks new ALS drug approval
pharmafile | May 28, 2015 | News story | Sales and Marketing | Eisai, Japan, als, mecobalamin
Eisai is hoping that existing neurology drug mecobalamin can be a new option for the difficult-to-treat condition amyotrophic lateral sclerosis (ALS) as it submits a new drug application in Japan.
Research funded by Japan’s Ministry of Health, Labour and Welfare suggested that ultra-high doses of mecobalamin could be effective in treating ALS, which led Eisai to begin its own studies.
Although the results of Eisai’s study suggested that mecobalamin could lead to a longer time to event and a slowing of disease progression when compared to placebo, a statistically significant difference could not be confirmed.
However, additional analyses showed that the drug was more effective in patient groups who commenced treatment within 12 months of ALS onset and those who had lower serum lipid levels.
“Considering ALS is an intractable, progressive disease with a poor prognosis that poses considerable impediments to daily life and greatly requires new treatment options, Eisai believes the agent can be useful in clinical settings for ALS given these results, and therefore has submitted an application for approval,” the company says in a statement.
Mecobalamin is marketed under the brand name Methycobal by Eisai and is used as a treatment for peripheral neuropathies and other conditions.
ALS is a neurodegenerative condition that causes severe muscle atrophy and weakness in the muscles. There is currently only one medicine approved for suppressing the progression of the disease in Japan.
Neurology is an area of focus for Eisai, and the company says it is looking into uncovering new indications for other existing drugs.
Its epilepsy treatment Fycompa (perampanel) was recently approved in Europe, although previously a major German health assessment body had said that the medicine offered ‘no additional’ benefit compared to conventional anti-epilepsy treatments.
Eisai’s portfolio has undergone some shakeups recently with patent losses of blockbusters such as Alzheimer’s drug Aricept (donepezil hydrochloride).
It also recently cut 25% of its US staff in an attempt to ‘ensure [the company] stays competitive in a rapidly changing business environment’.
George Underwood
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