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Curing Alzheimer’s With A New FDA Approved Drug: Does It Work?

16 August 21

Alzheimer’s has affected around 6 million people in the US , about 30 million worldwide, and is expected to double by 2050. At the moment, there are only five medications approved to delay cognitive decline in patients. 

Even though patient advocacy groups are pushing for treatments to get approved, the closest and most promising ones are most likely three or four years away from potential approval. 

However, earlier in June, the FDA approved a new drug making it the first in nearly two decades. Aducanumab, marketed as Aduhelm, is a monthly intravenous infusion designed to halt the cognitive decline in adults with mild memory and thinking impairments. This medication for Alzheimer’s targets the disease process rather than just the symptoms.

Clinical trials were conducted on patients with early-stage Alzheimer’s and higher-than-normal levels of amyloid. The FDA’s label of this drug did not specify who will benefit from it, rather they just said that it’s made “for the treatment of Alzheimer’s disease.”

The approval came with repercussions from the agency’s independent advisory committee and experts of Alzheimer’s. They claim that not enough evidence was clear in showing that the drug helps patients. 

Though it has been temporarily approved, the FDA requested the manufacturer, Biogen, to conduct a new clinical trial to demonstrate its effectiveness. If the Phase 4 trial fails to show considerable data, the FDA will probably rescind its approval. 

Some scientists are concerned that the approval of Aduhelm will lower the bar for future medications, allowing them to reach the market before experts in the field are sure that the benefits exceed the risks.

In this case, aducanumab’s side effects include brain swelling or bleeding, which occurred in around 40% of Phase 3 trial participants who received a high dose. The majority of participants were either asymptomatic or suffered headaches, dizziness, or nausea. Although no Phase 3 patients died due to the effects, one participant in the safety study did.

Several Alzheimer’s doctors who previously thought the argument for authorizing aducanumab was too weak, stated they now feel ethically obligated to make it available. They believe that many patients would presume there was a compelling justification for its FDA approval despite problematic evidence. 

Dr. David Knopman, a Mayo Clinic clinical neurologist and site lead investigator for one trial, stated that the evidence was insufficient to prove any benefit. He went on to mention that he “presented the data to the patient and her husband, and they didn’t hear a word I said about my concerns. All they heard was that there might be benefits.”

This drug has not yet been approved outside of the United States, but Biogen has applied for regulatory approval in the European Union, Japan, Brazil, and other countries.

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