Three FDA advisors resign after the approval of Alzheimer’s Drug on Monday

Just four days ago, we publish an article that talked about Aduhelm, an Alzheimer’s drug approved by the Food and Drug Administration.

The Food and Drug Administration gave the green light to Biogen (NASDAQ: BIIB) and Eisai (OTC: ESALY) and ever since then the two stocks have been enjoying a bullish run. However, latest news has three FDA advisors resigning after the approval which is very concerning.

Summary

  • Aduhelm, is a monthly infusion priced at $56,000 per year that was approved this week with weak evidence that is actually treating patients of Alzheimer’s disease.
  • However, latest news has three FDA advisors and scientists resigning after the approval.
  • The committee had found that the evidence did not convincingly show that Aduhelm could slow cognitive decline in people in the early stages of the disease — and that the drug could cause potentially serious side effects of brain swelling and brain bleeding.
  • The FDA said it would require Biogen to conduct another trail and it gave the company about nine years to complete it. But here is where the problem is, what if during those years and after the clinical trial the drug proves to be non-beneficial? Let’s not forget that during those years the drug will be available without restrictions.

 

Aduhelm, is a monthly infusion priced at $56,000 per year that was approved this week with weak evidence that is actually treating patients.

“This might be the worst approval decision that the F.D.A. has made that I can remember,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, who submitted his resignation Thursday after six years on the committee.

He said the agency’s approval of the drug, aducanumab, which is being marketed as Aduhelm, a monthly intravenous infusion that Biogen has priced at $56,000 per year, was wrong “because of so many different factors, starting from the fact that there’s no good evidence that the drug works.”

This approval has also led two other members to resignation, since they believe the committee’s dismay at the approval of the drug was overwhelmed rejected after reviewing its clinical trial in November.

The committee had found that the evidence did not convincingly show that Aduhelm could slow cognitive decline in people in the early stages of the disease — and that the drug could cause potentially serious side effects of brain swelling and brain bleeding, something that wasn’t mentioned on the day of the approval. “Approval of a drug that is not effective has serious potential to impair future research into new treatments that may be effective,” said Dr. Joel Perlmutter, a neurologist at Washington University School of Medicine in St. Louis, who was the first to resign from the committee.

“In addition, the implementation of aducanumab therapy will potentially cost billions of dollars, and these dollars may be better spent in either developing better evidence for aducanumab or other therapeutic interventions,” Dr. Perlmutter added.

Biogen plans to begin shipping the drug in about two weeks in more than 900 sites around the U.S.

“Giving patients a drug that doesn’t work and of course has important risks that are going to require multiple MRIs at a price of $56,000 a year is putting patients in a really challenging position and putting doctors in a difficult position as well,” Dr. Kesselheim said.

The members of the committee that resigned along after the approval have pointed out two major aspects. The main issue is that the FDA approved the drug for a much broader group of patients that includes anyone with Alzheimer’s even though the clinical trial were tested on patients with early stages of Alzheimer’s.

And second is FDA’s rationale in granting approval to the drug since the ability to actually treat the disease has not been proven and the side effects are equally bad. Besides, the trials didn’t not prove to be effective in attacking the amyloid protein in patients’ brains and neither that it helps slow their cognitive symptoms.

The FDA said it would require Biogen to conduct another trail and it gave the company about nine years to complete it. But here is where the problem is, what if during those years and after the clinical trial the drug proves to be non-beneficial? Let’s not forget that during those years the drug will be available without restrictions.

Bottom Line

 

The news is likely to push the stock downwards and will also cause a clash of trust from people towards the Food and Drug Administration. Pre-market is currently 0.5% down.

 

 

Disclaimer – I/we have no position in any stock mentioned. I wrote this article myself, and it expresses my personal opinions. I am not receiving any compensation for it, other than FDGT Academy. I do not have or had in the past any business relationship with any company that is mentioned in the above article.

Natalia C. - Junior Analyst at FDGT Academy

Natalia C. - Junior Analyst at FDGT Academy

I am a stock analyst/investor with prior experience and knowledge to BSc Accounting and Finance. After completing my degree and exposure to the accounting firms I decided that the direction I should choose is towards the Investment world. I completed my masters in Investment Management where it gave me solid fundamentals to build my career on. I have examined a lot of different aspects of investment, from REITS, derivatives, currencies, bonds, equity and hedge funds. I never stopped learning about the market which is why I can analyze and write articles for FDGT community always personally opinionated. My passion are green energy and electric vehicles stocks as a whole. I also had my share of analyzing the work form home stocks that are coming to take over in the upcoming years.

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