Approval for Aduhelm by FDA for the Treatment of Alzheimer’s Disease

An estimated 6.2 million Americans aged 65 and older live with Alzheimer’s dementia in 2021, as per the Alzheimer’s Association. The disease is more prevalent in the US than in any other place. Between 2000 to 2019, the death count from Alzheimer’s is doubled, increasing nearly 150% and making it the sixth leading cause of death in the US. Now, for the first time since 2003, the US Food and Drug Administration (FDA) has approved a new medication. A drug named Aduhelm (aducanumab), for the treatment of Alzheimer’s dementia – one that could help turn the trend around.

Meaning of Alzheimer’s dementia

 It includes changes in thinking skills and memory loss. Research from the Alzheimer’s Association has found that 1 in 9 people age 65 and older suffer from Alzheimer’s dementia.

Meaning of Aduhelm

In 2021, the FDA announced its approval of Aduhelm under the accelerated approval pathway process. The approval allows the FDA to fast-track a drug for a life-threatening or serious illness that may help more than existing treatments while the clinical benefit is still getting confirmed.

One possible reason why FDA chose to use the Accelerated Approval process for Aduhelm is because of the increased threat Alzheimer’s poses with the aging of the country’s population. As per the Alzheimer’s Association, more than 6 million Americans have Alzheimer’s currently. If we go by predictions, it is clear that by 2050, this number is projected to rise by nearly 13 million.

The accelerated approval process made the drug company study the drug to confirm its efficacy. Therefore, the FDA currently requires Biogen, the drug’s sponsor that helps in running the confirmatory trial and demonstrates its efficacy.

How does Aduhelm work

The main reason for Alzheimer’s disease could be due to the abnormal protein build-up in and around the brain cells. One of the involved proteins is called amyloid, and its deposit is formed by plaques around the brain cells. The other protein is called tau, and its deposits may form tangles within the brain cells. The plaque buildup-while not the definitive cause of Alzheimer’s dementia is known as the hallmark finding in the brain of the patients suffering from Alzheimer’s.

Aduhelm, administered as an intravenous (IV) infusion, is the first treatment that directs at reducing the presence of amyloid-beta plaques in the brain. The FDA records suggest that the clinical trials for aducanumab were the first to show that a reduction in these plaques is expected to lead to the reduction in the clinical decline of this form of dementia. But some controversy surrounds the drug before its approval echoes, and it is currently only expected in the reduction in amyloid plaque will help benefit the patients.

After the last stage of clinical trials of aducanumab, the trials were put on a halt. It happened when the results showed the drug was not better at slowing the cognitive impairment and memory loss impairment than placebo. Later that year, Biogen concluded that the drug did work when administered at higher doses.

Possible side effects of Aduhelm

The prescriber label of Aducanumab warns of a side effect called “amyloid-related imaging abnormalities (ARIA). It usually involves temporary bleeding or swelling in parts of the brain. A brain MRI must also obtain before treatment and before the seventh and twelfth infusion.

Other possible side effects of aducanumab include:

  • Disorientation
  • Delirium
  • Confusion
  • Diarrhea
  • Falling
  • Headache

Availability of Aduhelm

The shipping of Aduhelm is expected in about two weeks and make the drug available by late June. According to the company, there are more than 900 sites across the US estimated to be ready to provide it.

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