Innovative Alzheimer’s drug slows disease: A new era for treatment


July 17, 2023 | 10:53am

In the battle against Alzheimer’s disease, experts are excited about a new weapon.

A drug called donanemab, developed by Eli Lilly, has had a successful clinical trial and is expected to be approved by the Food and Drug Administration this fall.

People taking donanemab had a 40% lower risk of progressing from mild cognitive impairment to mild dementia or mild to moderate dementia.

If approved, donanemab would be the third Alzheimer’s drug to hit the market in recent months, after Leqembi and Aduhelm.

This is just the opening chapter of a new era of molecular therapies for Alzheimer’s disease, wrote Dr. Gil Rabinovici, director of the Memory and Aging Center at the University of California at San Francisco, in an op-ed for JAMA.

This will be a very important and significant drug, said Dr. Daniel Skovronsky, Lilly’s chief medical and scientific officer, as quoted in Fierce Biotech.

[T]”There’s a huge opportunity here for patients,” Skovronsky added.

Like Leqembi and Aduhelm, donanemab is a monoclonal antibody that attacks plaque in the brain, which is made up of a protein called amyloid.

Donanemab is expected to receive FDA approval in a matter of months.
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Amyloid plaques lead to the spread of another protein called tau. Both amyloid and tau proteins lead to the development of Alzheimer’s disease.

The donanemab study also found that the drug slowed cognitive decline by 35% compared to a placebo in people with low to intermediate levels of tau protein in their brains.

In fact, donanemab proved to be even more effective in removing amyloid plaques than Aduhelm or Leqembi.

And while Leqembi is meant to be taken for longer periods of time, patients taking donanemab can be on a fixed-duration dosing schedule, meaning they can take and stop in some cases.

I expect many patients will be able to stop dosing even after 12 months, Skovronsky said.

He added, “That’s a big difference from prescribing a drug that you may have to take for the rest of your life.” And I think that could be exciting and important for patients.

Despite the excitement, these new Alzheimer’s drugs have limitations and risks, experts noted.

The use of donanemab may be limited to people with mild Alzheimer’s disease.
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Donanemab and the other new drugs have been linked to brain swelling and bleeding. Three people in the donanemab clinical trial died from these side effects.

The risk of brain swelling and bleeding was higher among people with the APOE4 gene, which correlates with an increased risk of Alzheimer’s disease.

Additionally, people with more advanced cases of Alzheimer’s disease showed little or no benefit compared to those who took a placebo.

Therefore, donanemab might be limited to people with low to intermediate levels of tau protein, indicating mild disease.

Still, Skovronsky and other medical experts are optimistic that FDA approval will come soon.

With each passing day, there are some patients who go through this early stage of Alzheimer’s disease and become more advanced and will not benefit from treatment, Skovronsky said in an interview with CNBC. This is a very pressing sense of urgency.

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