is an article by members of the FDA scientific advisory committee that recommended that the FDA reject approval of Aducanumab [Ix4] until further study is completed. It was published on May 5th, 2021. The FDA later approved the drug on June 7th, 2021.
Prematureapproval . The premature approval of aducanumab could impede the development of other experimental treatments for Alzheimer’s disease for many years, potentially delaying progress on drugs that actually may turn out to be beneficial.
Reference [edit]
“FDA Reviewers: Why We Are Against Approval of Aducanumab.” n.d. Medscape. http://www.medscape.com/viewarticle/950565 .