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Biogen recently submitted an article to JAMA, a leading medical research journal, which analyzed the results of clinical trials of its new Alzheimer’s disease drug, Aduhelm. However, Biogen later withdrew the paper because JAMA considered rejecting it unless changes are made, according to two sources familiar with the matter.
Why is this important: The FDA’s decision to approve Aduhelm has been mired in controversy; experts say there is simply not enough solid data to show the drug works. And it looks like medical journal critics weren’t convinced by Biogen’s interpretation of the data either.
How it works: Pharmaceutical companies almost always publish clinical trial results in a peer-reviewed journal before get FDA approval, but Biogen still hasn’t done it for Aduhelm.
- Biogen executives said on a conference call last week that the company is working to publish Aduhelm’s Phase 3 results in a peer-reviewed journal.
When Axios asked about Biogen’s submission to JAMA, the company declined to answer questions beyond saying, “JAMA did not reject the post. Biogen has withdrawn the publication of JAMA and decided to pursue other publishing opportunities. “
- “To protect the integrity of the scientific review process, Biogen does not comment on publication deliberations with journals and their editors,” the company said in a follow-up statement.
- A JAMA spokesperson said: “Our policy is that we cannot confirm or deny that a manuscript is or has been under review.”
The central question are contrasting results from Biogen’s two late stage trials, both of which compared Aduhelm (also known as aducanumab) to placebo. The company halted the studies in 2019 after initial readings showed the drug was not working.
- One of the attempts was completely unsuccessful.
- The second trial was initially considered unsuccessful, but Biogen conducted an afterthought that found a subset of patients who had reduced levels of amyloid, which are sticky plaques that build up around neurons in the body. brain, and did a little better cognitively. testing.
- The FDA used this lowered amyloid finding as a “surrogate” measure and as the basis for expedited approval.
- The reasoning of the FDA contradicted its own guidelines on Alzheimer’s disease drugs. Agency officials also explicitly told outside experts, who almost unanimously believed the drug should not be approved, that they were not considering expedited approval.
- Biogen is now selling Aduhelm, which also carries risks of brain swelling and bleeding, and has up to nine years to complete a post-approval trial confirming the drug’s effectiveness.
Between the lines: Doctors and researchers often read full clinical trial data in journals to validate pharmaceutical companies’ claims about the drugs. They still don’t have that option for Aduhelm.
- “I suspect [Biogen] is reluctant to allow the full data to go through a more in-depth review than the peer review process would provide, ”said Scott Emerson, a University of Washington biostatistician and a member of the FDA committee who voted against Aduhelm, to Zach Brennan from Endpoints News last month.
Go further: Biogen’s Attempt to “Shine the Light on the Whole Industry”
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