The FDA wrote that despite some concerns about the treatment, the benefits "outweighed the risks"

By Maria Pasquini
June 07, 2021 01:47 PM
Dr. William Burke goes over a PET brain scan at Banner Alzheimers Institute in Phoenix
Credit: Matt York/AP/Shutterstock

The Food and Drug Administration approved a new Alzheimer's treatment for the first time in almost 20 years.

On Monday, the FDA announced that it had approved a medication called aducanumab — sold under the brand name Aduhelm — which is the first treatment to specifically address the loss of "cognitive functioning over time" associated with Alzheimer's. Many people who suffer from the disease end up losing their ability to speak, understand and recognize their loved ones.

Aducanumab aims to "reduce amyloid beta plaques in the brain," which "is expected to lead to a reduction in the clinical decline of this devastating form of dementia." According to the Alzheimer's Association, plaques are abnormal clusters that can build up to "block cell-to-cell signaling."

The approval process came through its Accelerated Approval Program, which allows for "earlier approval of drugs that treat serious conditions, and that fill an unmet medical need." 

In a nod to the controversy surrounding the drug, the FDA noted that experts have "offered differing perspectives" about the treatment, and "there has been considerable public debate" surrounding its approval.

"The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint," they wrote.

Some critics of the drug are also concerned that symptoms can include brain swelling and tiny brain bleeds, while others worry about the potential cost of the treatment, according to The Washington Post.

Additionally, an advisory committee determined last year that there was not enough evidence to support approving treatment.

The FDA went on to write that in all of the studies, the drug "consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion."

"At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward," the agency wrote, adding that it ultimately "concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweighed the risks of the therapy."

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Biogen, which manufactures the drug, will be required to conduct post-approval studies to determine whether the drug is effective.  

"If the confirmatory trial does not verify the drug's anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market," the FDA wrote. 

"With all this said, we are extremely aware of the gradual and cumulative devastation that Alzheimer's disease causes, as patients lose their memory and cognitive functioning over time," they continued, noting that "the need for treatments is urgent." 

According to the Centers for Disease Control and Prevention, in 2020, as many as 5.8 million Americans were living with Alzheimer's — and that number is expected to nearly triple by 2060. The disease is the sixth leading cause of Death in the United States, and the fifth among those aged 65 and older.

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On behalf of those impacted by Alzheimer's and all other dementia, the Alzheimer's Association welcomes and celebrates today's historic FDA approval of aducanumab for Alzheimer's disease," Harry Johns, Alzheimer's Association president and CEO, said in a statement. 

"This approval allows people living with Alzheimer's more time to live better. For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope," he said.

Ronald C. Petersen, director of the Mayo Clinic's Alzheimer's Disease Research Center, has also said that while the approval is "good news," the medication does not represent a cure.  

"This is good news for patients with Alzheimer's disease. We've not had a disease modifying therapy approved ever," he said, according to Reuters

"This is a big day," he added. "But we can't overpromise."