A timeline of Aduhelm's approval and the fallout since

The FDA approved Biogen's drug Aduhelm June 7, sparking controversy in the healthcare community with critics who say there isn't enough scientific evidence that the drug works, and there is evidence that it can have severe side effects on the brain. 

The drug is designed to target and eliminate clumps of a toxic protein called beta amyloid that are believed to destroy the brain. It's the first drug approved to treat cognitive decline caused by Alzheimer's instead of treating symptoms of the disease.

Below is a timeline of the steps leading to Aduhelm's approval, as well as the fallout since: 

March 2019: Biogen halts two late-stage trials for aducanumab, the generic name of the drug, after an analysis shows it is unlikely to work. The company loses billions of dollars in market value. FDA reviewers later say a deep look into the trial data suggests a small number of patients in one of the trials may have skewed it. 

Oct. 22, 2019: Biogen announces it plans to seek regulatory approval for aducanumab. The company's shares spike more than 26 percent. It says its decision to seek approval comes after a new analysis of a larger dataset showed the drug reduced clinical decline in patients with early Alzheimer's. CEO Michel Vounatsos says he is "confident" the drug will get the FDA's approval.

Nov. 4, 2020: A group of FDA reviewers appears to endorse aducanumab, indicating it believes the drug is sufficiently safe and effective.

Nov. 6, 2020: The FDA's advisory committee votes 10-1 against approving aducanumab, saying data from clinical trials isn't enough to prove it works to slow cognitive decline, contradicting the reviewers who seemed to endorse the drug. Brian Skorney, an analyst at Baird, an investment bank, writes in a note to investors: "We think approving aducanumab, in the face of such an overwhelmingly negative vote and commentary, is virtually impossible and would destroy the [FDA's] reputation at a very tenuous time for the regulator, ahead of potential actions on COVID vaccines."

June 7, 2021: The FDA approves aducanumab, and it becomes the first new Alzheimer's drug approved in 18 years. Biogen brands it as Aduhelm. The FDA places no restriction on which Alzheimer's patients can get the drug, meaning more than 6 million Americans living with Alzheimer's are eligible for a monthly intravenous infusion of it.

June 7, 2021: Biogen and its development partner, Eisai, say Cigna is entering a value-based contract with Biogen for Aduhelm, under which the companies will track patient outcomes and performance. Biogen and Eisai also say they are working with CVS Health on cognitive screenings, which are to begin Sept. 14 in large cities.

June 8, 2021: Aduhelm is priced at $56,000 per year, a price Mr. Vounatsos calls "fair" and says is a reflection of "two decades of no innovation." He pledges that Biogen won't raise the price for the next four years. Experts in the pharmaceutical industry predict Aduhelm will become one of the best-selling pharmaceutical products in the world. Medicare hasn't made a coverage determination on the drug, but an estimate from the Kaiser Family Foundation predicts beneficiaries could pay up to $11,500 in coinsurance for a year of Aduhelm.

June 9, 2021: Joel Perlmutter, MD, a neurologist on the FDA's advisory committee, resigns following the FDA's decision to approve Aduhelm over the committee's objection.  

June 10, 2021: David Knopman, MD, a clinical neurologist from Mayo Clinic in Rochester, Minn., follows Dr. Perlmutter in resigning from the FDA's advisory committee, saying he did not "wish to be part of a sham process" that led to the FDA's approval of Aduhelm. 

"The whole saga of the approval of aducanumab … made a mockery of the [advisory] committee's consultative process. While I realize that the committee is advisory, the approval of aducanumab appears [to] have been foreordained," he writes in an email to FDA officials.

June 11, 2021: Aaron Kesselheim, MD, becomes the third member of the FDA's advisory committee to resign over the FDA's decision to approve Aduhelm. He says in his resignation letter that the decision "was probably the worst drug approval decision in recent U.S. history." 

June 16, 2021: Butler Hospital in Providence, R.I., part of the Care New England health system, becomes the first hospital to administer Aduhelm to a patient outside of a clinical trial.

June 16, 2021: Public Citizen, a Washington, D.C.-based consumer advocacy group, writes a letter to HHS Secretary Xavier Becerra calling on him to remove the FDA's acting commissioner Janet Woodcock, MD; Patrizia Cavazzoni, MD, director of the agency's Center for Drug Evaluation and Research; and Billy Dunn, MD, director of the Center for Drug Evaluation and Research's office of neuroscience, after Aduhelm's approval. The letter states the FDA "showed a stunning disregard for science," in its decision to approve the drug. 

June 16, 2021: A report released by research nonprofit Altrarum finds that Aduhelm could single-handedly represent 1 percent of all national healthcare expenditures by the mid-2020s. 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars