U.S. House Panels to Probe into Approval of New Alzheimer's Drug
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New York, June 25 (Jiji Press)--Two U.S. House committees said Friday they will examine the approval and pricing of aducanumab, a new remedy for Alzheimer's disease developed jointly by Japan's Eisai Co. <4523> and U.S. biopharmaceutical company Biogen Inc.
Chairman Frank Pallone of the Committee on Energy and Commerce and Chairwoman Carolyn Maloney of the Committee on Oversight and Reform said in a statement that they have "serious concerns about the steep price" of aducanumab and "the process that led to its approval despite questions about the drug's clinical benefit."
The new remedy won the U.S. Food and Drug Administration's approval earlier this month and became available for users.
Although clinical trials for aducanumab were only conducted on early-stage Alzheimer's patients with mild cognitive impairment, the drug's label indicates that it can be used broadly for the treatment of Alzheimer's disease, the statement said.
On aducanumab, an advisory committee to the FDA pointed out that the efficacy of the drug has not been proved sufficiently. After the drug's approval, three members of the advisory committee resigned in protest.
[Copyright The Jiji Press, Ltd.]