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When the world boiled over when Biogen's new Alzheimer's drug Aduhelm was approved by the US Food and Drug Administration (FDA) for marketing, the three experts on the FDA's Expert Advisory Committee left their posts "angry"
.
Two experts voted against the drug's listing, and one expert did not participate in Aduhelm's expert advisory committee meeting due to past experience
In November 2020, after Biogen submitted Aduhelm's new drug marketing application, 10 of the 11 experts voted against it in the advisory committee meeting because Biogen did not provide sufficient evidence to prove that the drug can slow down cognitive decline , 1 expert abstained from voting
.
Although the panel of experts rejected the drug with an overwhelming vote, the FDA approved the therapy a few days ago
After learning of the news, Joel Perlmutter, a neuroscientist at Washington University in St.
Louis, who had voted against, resigned on the same day.
He said that his resignation was "due to the FDA's ruling, and no further discussion with our advisory committee
.
"
Aaron Kesselheim, another panel member who voted against and resigned, has been serving on the FDA's Neurological Therapy Advisory Committee since 2015
.
In a letter to Janet Woodcock, Acting Commissioner of the FDA, he proposed to approve Biogen's Aduhelm "probably the worst drug approval decision in the recent history of the United States
In fact, the FDA may not follow the voting results of the expert committee, but judging from previous approvals, this situation often occurs when the expert group has similar votes
.
As for Biogen's Aduhelm, the expert group almost all voted against it
Another contradiction is that Billy Dunn, director of the Office of Neurosciences of the FDA, clearly stated in the advisory committee meeting that "amyloid is not considered as a therapeutic alternative", but in this approval, the FDA is based on the level of amyloid.
As an alternative end point, Aduhelm's marketing authorization was passed
.
Regarding this change, Billy Dunn explained: “We realize that the public is very optimistic about Aduhelm and that there is different evidence to support the further application of Aduzumab
.
Before accelerating the approval of the drug, the FDA has fully considered internal and external Opinion
However, in the opinion of the experts of the expert group, this accelerated approval decision made by the FDA is undoubtedly dangerous
.
Aaron Kesselheim, a member of the expert committee and director of the Brigham and Women’s Hospital Supervision, Therapeutics and Legal Program, said the decision not only sets a “dangerous precedent for what kind of evidence needs to be shown for Alzheimer's treatment drugs to be approved.
", and may have set a precedent, indicating that "when a company's primary clinical endpoint does not reach the level required for FDA approval, the company can seek (accelerated approval) at the last minute
.
"
Undoubtedly, the approval of Aduhelm has once again ignited the confidence of researchers to march into Alzheimer's disease, but how to evaluate this accelerated approval decision by the FDA is still worth thinking about
