Aduhelm (aducanumab) Updates

Editor's note: Aduhelm™ (aducanumab) was discontinued on November 1, 2024. It was not discontinued due to safety or efficacy reasons. People taking Aduhelm should talk to their doctor as soon as possible to determine the next steps for their treatment plan.

Aduhelm™ (aducanumab) is a drug used to treat Alzheimer’s disease. When the US Food and Drug Administration (FDA) approved Aduhelm in June 2021, it was exciting news. Aduhelm was the first new drug for Alzheimer’s approved in 18 years.¹

However, the approval of Aduhelm was controversial. The FDA then issued a revised approval only a month later.²

In February 2024, Biogen, the maker of Aduhelm, announced that the drug will be discontinued before the end of the year.³

Aduhelm discontinuation

Aduhelm is no longer available via prescription as of November 1, 2024.³

Biogen said it discontinued Aduhelm "to reprioritize its resources in Alzheimer's disease." Aduhelm was not discontinued due to safety or efficacy reasons.³

If you or a family member are taking Aduhelm, talk to your clinical trial contact and/or doctor about how these changes impact your treatment and care.

Original Aduhelm approval

The FDA granted Aduhelm accelerated approval in June 2021. The FDA may give accelerated approval to new drugs that treat health conditions with few or no other treatments. It usually allows the drug to be sold sooner. Continued approval is based on results from larger trials showing a drug helps patients.¹

Some people believe the FDA approved Aduhelm in part because of the influence of Alzheimer’s patient groups. Some of these groups were excited about the idea of the first new Alzheimer’s treatment in a long time. They intensely lobbied the FDA in support of Aduhelm.^2,4

But many doctors disagreed with the FDA’s original approval. They felt there was not enough evidence to prove Aduhelm worked. There were also concerns about side effects and who was included in the first study.^2,4

For example, Aduhelm can cause brain swelling and brain bleeding. This may make the drug more dangerous for people with certain health conditions. Also, people with diabetes or high blood pressure and those on blood thinners did not take part in the trials. This means doctors do not know whether these people can take the drug safely.²

Also, the Aduhelm study only included people with mild cognitive impairment or dementia. But the FDA approved Aduhelm for any person with Alzheimer’s disease. This included those with moderate or severe Alzheimer’s. Doctors felt there was not enough evidence that this was a safe decision.²

Revised Aduhelm approval

The FDA issued a revised approval in July 2021. The approval included only the types of people who were part of the drug's clinical trials. This means it was only approved for people with mild cognitive impairment or dementia.²

The original approval would have given roughly 6 million Americans a new drug for Alzheimer's disease. The new, more limited use means that about 2 million people can use this treatment.¹

Insurance coverage

Even after the revised approval, some doctors refused to prescribe Aduhelm. Large providers such as Cleveland Clinic and Mount Sinai announced that they will not administer Aduhelm.^4,5

Biogen announced the cost of Aduhelm is $56,000 a year. Doctors, insurance companies, and nonprofits say this price is too high for a treatment that may not work.⁶

Some insurance companies also announced that they would not cover the cost of Aduhelm. This decision was based on the belief that Aduhelm is still experimental.⁵

Other controversies

In July 2021, two congressional committees opened an investigation into interactions between the FDA and Biogen. A report issued after the 18-month investigation stated that the approval was "rife with irregularities" and "raised serious concerns about FDA's lapses in protocol."⁷

In a statement following the report, the FDA said, "We fully cooperated with the committees' evaluation and we continue to review their findings and recommendations." A statement from Biogen said the company "stands by the integrity of the actions we have taken" and "Alzheimer’s is a highly complex disease, and we have learned from the development and launch of Aduhelm."⁷