Safety Data for Alzheimer’s Drug Aduhelm Shows: 40 % of the Participants in the Study Have Brain Swelling or Bleeding

Experts’ opinions on the new treatment for Alzheimer’s in 18 years are varied.

Back in June 2021, the FDA approved aducanumab, the first new treatment for Alzheimer’s after 18 years.

The medication is now named Aduhelm and it’s made by Biogen. It’s full of controversy and the information is piling up.

In fact, recent JAMA Neurology-published safety data for this medication showed that a lot of participants who took the drug had brain bleeding or swelling. 

What does this mean for the success of this drug and its further use in the treatment of this degenerative illness?

Aduhelm’s Caused Brain Swelling & Bleeding in the Participants

In 425 of the 1029 participants, 41 percent experienced brain swelling and bleeding. 

Of them, 362 had swelling while 94 experienced symptoms associated with the swelling such as dizziness, confusion, headaches, and nausea. 

The study indicates that those who experienced swelling had it early on, particularly after receiving a high dosage. 

The MRIs showed that those with bleeding or swelling were with a mild or moderate level of seriousness. But, 12 percent of the affected experienced serious swelling.

Although no one died during the trials, a 75-year-old female participant died in September while taking the drug. She hasn’t been publicly identified and had to spend time in the hospital after taking the drug.

She got swelling in the brain prior to dying. But, it’s not yet clear if she died because of the drug or due to another reason. According to Biogen, they’re working with the reporting physician and global regulators to learn more about the case.

A lot of Criticism & Celebration Around Aduhelm 

This medication has been celebrated and criticized since its approval in the summer of 2021. 

Despite the medication being great news for individuals with Alzheimer’s and their families, according to the president and CEO of the Alzheimer’s Association Harry Johns, the independent advisory committee of the FDA voted in November against the recommendation for aducanumab’s approval. 

They cited insufficient proof that the medication is actually able to slow down the decline in cognition as the major reason.

Moreover, scientists from the non-profit Institute for Clinical and Economic Review released a report claiming there’s a lack of information showing that the benefits of this medication outweigh the risks.

Other organizations were also against it, including the American Geriatrics Society. They considered the approval premature because of the insufficient data supporting the ability of the drug to lower the progression of Alzheimer’s. 

The approval of the drug by the FDA is quite unusual: they gave it an accelerated path for approval. This allows those with the disease to get access to the drug earlier if there’s an expectation of advantages, despite any associated issues with the drug’s success rate.

The agency notes that Biogen has to verify the clinical benefits in a post-approval trial. If they don’t, the approval may be pulled back. 

How Does Aducanumab Work?

This amyloid beta-directed antibody drug targets the plaques of the amyloid present in brains of the people with Alzheimer’s. 

These plaques contain toxic proteins and they collect between the neurons and diminish the functioning of the cells. 

Patients were given the drug via a monthly IV infusion. This is the first approved treatment for dementia that influences the process of the disease, rather than only the symptoms. 

The trials for the drug showed that reducing these plaques will help decrease the clinical decline common with this dementia.

The drug was included in two phase-3 clinical trials and given to 3285 participants. They had early Alzheimer’s and were from 348 areas in 20 countries.