Aduhelm™ (aducanumab) Controversy and Updates

Aduhelm™ (aducanumab) is a drug made by Biogen to treat Alzheimer’s disease. When the US Food and Drug Administration (FDA) first approved Aduhelm, 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. And the FDA issued a revised approval only a month later.²

Original aducanumab approval

In June 2021, the FDA granted Aduhelm accelerated approval. 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.^2,3

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.^2,3

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 Alzheimer’s patient. 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 refuse to prescribe Aduhelm. Large providers such as Cleveland Clinic and Mount Sinai have announced that they will not administer Aduhelm. They may change this decision if new information becomes available.^3,4

Biogen has announced the cost of Aduhelm will be $56,000 a year. Doctors, insurance companies, and nonprofits have said this price is too high for a treatment that may not work.⁵

Some insurance companies have announced that they will not cover the cost of Aduhelm. This decision is based on the belief that Aduhelm is still experimental.⁴

Other controversies

On July 9, the head of the FDA called for an investigation into interactions between the FDA and Biogen.⁶

Read more about Aduhelm here.