FDA panel concluded there is not enough evidence to support the clinical effectiveness of aducanumab<\/p>\n<\/h3>\n
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MONDAY, Nov. 9, 2020 (HealthDay News) — An experimental Alzheimer disease treatment should not be approved by the U.S. Food and Drug Administration, an agency advisory panel says.<\/p>\n
The panel reviewed clinical data on the drug aducanumab and concluded that there is not enough evidence to support its clinical effectiveness, CNN<\/em> reported. The drug, developed by the pharmaceutical company Biogen and its Japanese partner Eisai, is administered through intravenous infusion for early Alzheimer disease.<\/p>\n “There’s a huge danger in approving something that turns out not to be effective,” said panel member Joel Perlmutter, M.D., in Friday’s meeting, CNN<\/em> reported. “If we approve something when the data is not strong, we have a risk of delaying good treatments and effective treatments for more than a couple of years, for many years.” <\/p>\n The panel’s recommendation will be taken into account by the FDA as it decides whether or not to approve the drug. It’s been nearly 20 years since the agency approved a new drug for Alzheimer disease, CNN<\/em> reported.<\/p>\n