(Reuters) – The U.S. Meals and Drug Administration, citing battle of curiosity, has recused a member of an 11-person advisory committee set to overview Biogen Inc’s experimental Alzheimer’s drug aducanumab on Friday.
Mayo Clinic neurologist Dr. David Knopman confirmed on Monday that he was recused from the scheduled assembly of outdoor advisors to the FDA. Knowledgeable advisory panels typically play an necessary position forward of FDA approval choices, though the company shouldn’t be required to take their recommendation.
Knopman, who mentioned he was recused due to his involvement in conducting medical trials of aducanumab, has been a vocal critic of the drug, together with in a paper revealed on Sunday within the journal Alzheimer’s & Dementia.
“Aducanumab’s efficacy as a therapy for the cognitive dysfunction in Alzheimer’s illness can’t be confirmed by medical trials with divergent outcomes,” he wrote (https://bit.ly/35QmxHm).
The FDA, which is slated to determine by early March whether or not to approve aducanumab, didn’t instantly reply to a request for remark.
If authorized, aducanumab could be the primary drug to deal with an underlying reason behind the deadly, mind-wasting illness, a area that has for many years produced nothing however failure. By 2025, the variety of folks age 65 and older with Alzheimer’s dementia is projected to achieve 7.1 million in the US alone, in keeping with the Alzheimer’s Affiliation.
Biogen has mentioned aducanumab, an antibody designed to take away dangerous plaques from the mind, was proven in one in every of two main research to considerably sluggish cognitive and practical decline. A second trial, nonetheless, confirmed a profit just for a subset of sufferers who got a excessive dose for a minimum of 10 months.
Biogen abruptly ended a pivotal trial of aducanumab final yr after an early take a look at outcomes urged it didn’t present a desired profit. Months later, the biotech firm shocked many by reversing course, saying it had determined to hunt FDA approval in any case.