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Eli Lilly and Company’s pharmaceutical manufacturing facility is pictured at 50 ImClone Drive in Branchburg, New Jersey on March 5, 2021.
Mike Segar | Reuters
Treatment of Alzheimer’s disease donanemabwhich manufactures it Eli Lillysignificantly slowed the progress of the mind robbery diseaseaccording to clinical trial data released by the company on Wednesday.
In the 18-month study, patients who received a monthly infusion of the antibody showed a 35% slower decline in memory, thinking and their ability to perform daily activities compared to those who did not receive treatmentdata from Eli Lilly showed.
According to the trial results, patients taking donanemab were 39% less likely to progress to the next stage of the disease during the study.
But the benefits of treatment will need to be weighed against the risk of brain swelling and bleeding, which can be serious and, in rare cases, fatal. Three trial participants died from these side effects.
Lilly plans to apply for Food and Drug Administration approval of donanemab as soon as this quarter, according to the company. The trial looked at individuals in the early stages of Alzheimer’s disease who had the confirmed presence of brain plaques associated with the disease.
dr. Daniel Skovronsky, Lilly’s chief scientific and medical officer, said the company is working to get donanemab approved and on the market as soon as possible.
And Skovronsky believes the FDA feels the same way necessity.
“Every day that goes by, there are some patients who go through this early stage of Alzheimer’s disease and become more advanced and will not benefit from treatment,” he said in an interview with CNBC. “It’s a very pressing sense of urgency.”
Lilly previously applied for accelerated approval for donanemab.
The FDA rejected that request in January and asked the company for more data on patients who had received the antibodies for at least 12 months. Lilly said the data wasn’t available at the time because many patients were able to stop dosing after six months because the treatment quickly cleared plaque.
Nearly half of the patients — 47% — who received donanemab showed no disease progression a year after starting treatment, compared with 29% who did not receive the antibody, according to data released Wednesday.
More than half of the patients completed treatment within the first year and 72% completed it within 18 months due to the removal of brain plaques.
In a separate measure, patients receiving donanemab showed 40% less decline in ability to perform daily activities after 18 months. This means they could manage finances, drive, engage in hobbies and hold conversations better than those who did not receive treatment.
Reduction of brain plaques
Donanemab targets brain plaques associated with Alzheimer’s disease. According to Lilly, the treatment significantly reduced plaque as early as six months after treatment. Many patients saw such a significant reduction that they tested negative for plaque on PET images, according to the company.
After six months, donanemab cleared plaque in 34% of patients who had intermediate levels of a protein called tau, which can become toxic and destroy neurons. After 12 months, donanemab cleared plaque in 71% of patients with the same tau levels.
“It should be clear that plaque-removing drugs, especially if you can completely remove plaque and do it quickly, can produce very significant clinical benefits for the patient,” Skovronsky said in an interview.
“The earlier you do it in the course of the disease, the more you can slow the disease,” he said.
dr. Eric Reiman, executive director of the Banner Alzheimer’s Institute, said the results don’t necessarily mean the plaques have completely disappeared, but that donanemab cleared the plaques to the point that the treatment removed measurable evidence of them. The Banner Alzheimer’s Institute had two physicians involved in the donanemab trial as principal investigators.
Risk of brain swelling and bleeding
Donanemab can cause brain swelling and bleeding in patients, which can be severe and even fatal in some cases. Three trial participants died from these side effects, Lilly says.
These types of side effects have been seen with other Alzheimer’s antibody treatments, such as Eisai and Biogen Leqembiwhich received accelerated FDA approval in January.
Reiman said he is encouraged by the potential clinical benefit for patients, but it is important that the risks are clear.
“We also need to be clear that there are side effects, including an unusual but potentially catastrophic risk,” Reiman said. “And we must continue to do our best to understand what that risk is for individual patients, to inform patients and family caregivers, and to do everything we can to mitigate that risk,” he said.
About 24% of patients receiving donanemab showed brain swelling on MRI, but only 6% showed actual symptoms. About 31% of patients had small brain bleeds, called microhemorrhages, compared with 13.6% of patients who did not receive the treatment.
Lilly said most cases of brain swelling and bleeding were mild to moderate and that patients stabilized with the right care, but warned that serious and life-threatening events could occur. About 1.6% of swelling and bleeding cases were serious, Lilly says.
Skovronsky said each patient should talk to their doctor, who weighs the potential benefits of donanemab against the potential risks.
“Based on the population, our view is that the benefits outweigh the risks,” Skovronsky said.
“The FDA is the custodian of this for the U.S.,” he said of the risk-benefit analysis that will determine whether donanemab gets approval.
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