Alzheimer's Rx Gets Green Light

FDA approves Aduhelm (aducanumab) to treat Alzheimer's

(RxWiki News) The last time the US Food and Drug Administration (FDA) approved a treatment for Alzheimer's disease was 2003. Eighteen years later, the agency has finally approved a new Alzheimer's treatment.

That treatment is called Aduhelm (aducanumab). While some are celebrating this approval, the decision has come with some controversy.

That's because the FDA approved this treatment against the recommendation of its own advisory panel not to approve it.

The Peripheral and Central Nervous System Drugs Advisory Committee met in late 2020 to discuss Aduhelm. The committee believed the evidence that the drug was effective was not strong enough.

After the committee met and provided feedback, the FDA continued to review the data and decided that the evidence met the standard for accelerated approval.

Accelerated approval means a drug's approval pathway is fast-tracked because it provides a meaningful therapeutic benefit. Through this process, the manufacturer of Aduhelm needs to conduct a trial to show that the drug works. The FDA can take back the approval if this trial does not happen or it shows that the drug isn't effective.

The FDA based its initial approval on three clinical trials that included more than 3,300 patients with Alzheimer's disease.

Aducanumab's approval marks the first new treatment approved for Alzheimer's since 2003. It's also the first treatment to target beta-amyloid, the underlying disease process of Alzheimer’s.

According to the FDA, those who received Aduhelm in trials had a reduction in beta-amyloid plaque when compared to those who did not receive this drug. This reduction is expected to result in slowed clinical decline due to Alzheimer's, the agency said.

Those with Alzheimer's have plaques and tangles in their brains. These are abnormal buildups of different proteins. Specifically, the beta-amyloid protein clumps up and forms plaques in between the brain cells. This drug targets one of those plaques, beta-amyloid, which is tied to Alzheimer's.

Common side effects of Aduhelm may include headaches, falls, diarrhea and altered mental status (such as disorientation and confusion or delirium).

Another possible side effect is amyloid-related imaging abnormalities due to temporary swelling in areas of the brain. This usually resolves over time and may or may not cause symptoms. Symptoms may include headache, confusion, dizziness, vision changes and nausea.

The FDA granted this approval to Biogen.