The makers of the controversial drug Aduhelm, Biogen, withdrew its paper that analysed the drug’s results that was submitted to medical journal JAMA, as reported in Axios reported on Tuesday, citing two sources familiar with the matter.
Biogen submitted the paper to JAMA, a top medical research journal, that analysed clinical trial results.
However, Biogen then withdrew the paper because JAMA considered rejecting it unless edits were made, according to two sources familiar with the matter.
The FDA approved Biogen’s Aduhelm despite all of its advisory panel members voting against the drug’s approval, and three panel members resigned in protest.
The approval has been highly controversial, with many experts claiming that the drug does not work, and there has been much criticism of the $56,000 per year price tag. The approval is currently under review by the FDA, which is highly unusual.
When Axios asked about Biogen’s submission to JAMA, the company declined to answer questions beyond saying, “JAMA did not reject the publication. Biogen withdrew the publication from JAMA and decided to pursue other publication opportunities.”
Biogen has begun work on another Alzheimer’s drug, BIIB080/IONIS-MAPTRx, which met its primary objective of safety and tolerability in patients with mild Alzheimer’s disease in a Phase 1b trial.
Alfred Sandrock, Jr., Head of Research and Development at Biogen said of the results: “Biogen is deeply committed to the development of novel treatments for patients with Alzheimer’s disease. This commitment extends across multiple modalities, including antisense oligonucleotides, as with BIIB080.
“Biogen is encouraged by the results of this trial, and we look forward to our continued research in future clinical studies with this promising investigational asset.”
Scott Emerson, a University of Washington biostatistician and a member of the FDA committee who voted against Aduhelm, told Zach Brennan of Endpoints News last month: “I suspect [Biogen] is reluctant to have the full data undergo the greater scrutiny that the peer review process would provide.”
Lilly Subbotin
This is a syndicated feed from Pharmafile
