An Eli Lilly and Company pharmaceutical factory is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.
Mike Segar | Reuters
Treating Alzheimer’s Disease donanemabcreated by Eli Lillysignificantly slows down the mind hijacking process sickaccording to clinical trial data released by the company on Wednesday.
Patients who received monthly antibody infusions in an 18-month study demonstrated a 35% slower decline in their memory, thinking ability, and ability to perform daily activities than patients who did not. antibodies are given. treatmentEli Lilly’s data shows.
According to the trial results, patients taking donanemab were 39% less likely to progress to the next stage of their disease during the study.
But the benefits of treatment will have to be weighed against the risk of brain swelling and bleeding that can be serious and even fatal in rare cases. Three trial participants died from these side effects.
Lilly plans to sign up Food and Drug Administration The company says donanemab will be approved as soon as this quarter. The trial studied individuals in the early stages of Alzheimer’s who had been confirmed to have the presence of brain plaques associated with the disease.
Daniel Skovronsky, Lilly’s chief medical and scientific officer, said donanemab demonstrated the highest level of effectiveness of any Alzheimer’s treatment in a clinical trial. He said the company is working to get donanemab approved and marketed as quickly as possible.
And Skovronsky believes the FDA feels the same way urgent.
“Every day that goes by, there are some patients who get past the early stages of Alzheimer’s and get worse and they won’t get treatment,” he said in an interview with CNBC. “It’s a very urgent sense of urgency.”
Lilly has previously applied for donanemab expedited approval.
The FDA declined that request in January and asked the company for more data on patients who had received antibodies for at least 12 months. Lilly said data was not available at the time because many patients were able to stop taking the drug after six months because the treatment removed the plaque quickly.
Nearly half of the patients — 47% — who received donanemab showed no improvement a year after starting treatment, compared with 29% who did not receive the antibodies, according to data released Wednesday.
More than half of the patients completed treatment within the first year and 72% completed treatment in 18 months due to brain plaque clearing.
In a separate measure, patients taking donanemab showed a 40% decrease in their ability to perform daily activities after 18 months. This means they are better able to manage their finances, drive, pursue hobbies and chat than those who do not receive treatment.
Maria Carrillo, chief scientific officer of the Alzheimer’s Association, said: “This is the strongest phase 3 data on Alzheimer’s treatment to date. This further underscores the inflection point we are having for the field. Alzheimer”.
Reduce brain plaque
Donanemab targets brain plaque associated with Alzheimer’s disease. According to Lilly, the treatment significantly reduced plaque as early as six months after treatment. According to the company, many patients have seen such a dramatic reduction that they have tested negative for the presence of plaque on PET scans.
Donanemab cleared plaque after six months in 34% of patients whose moderate levels of a protein called tau can become toxic and kill neurons. After 12 months, donanemab cleared plaque in 71% of patients with the same tau levels.
“It’s clear that plaque-removing drugs, especially if you can get rid of the plaque completely and do it quickly, can have very significant clinical benefits,” Skovronsky said in an interview. for patients”.
“The earlier you do this in the course of treatment, the more you can slow the disease down,” he says.
Dr Eric Reiman, executive director of the Banner Alzheimer’s Institute, said the results did not necessarily mean the plaque was gone completely, but donanemab cleared the plaque to such an extent that the treatment removed evidence. it can be measured. Alzheimer’s Banner Institute has two doctors participating in the donanemab trial as principal investigators.
Brain swelling and risk of bleeding
Donanemab can cause brain swelling and bleeding in patients, which in some cases can be serious and even fatal. According to Lilly, three trial participants died from these side effects.
These types of side effects have been observed in other Alzheimer’s antibody treatments such as Eisai’s and Biogen’s. Leqembireceived rapid FDA approval in January.
Reiman said he is encouraged by the potential clinical benefit for patients but it’s important to be clear about the risks.
“We also need to be clear that there are side effects, including uncommon but potentially catastrophic risks,” Reiman said. “And we need to continue to do our best to understand what that risk is for each individual patient, to inform patients and family caregivers, and do everything we can to reduce that risk.” he said.
About 24% of patients taking donanemab presented with brain swelling on MRI, but only 6% had actual symptoms. About 31% of the patients had a small brain bleed called a microbleed, compared with 13.6% in the untreated patients.
Lilly said the majority of cases of brain swelling and bleeding were mild to moderate and patients were stable with proper care, but warned that serious and life-threatening events could occur. go out. According to Lilly, about 1.6% of cases of swelling and bleeding are serious.
Skovronsky said every patient will need to discuss it with their doctor to weigh the potential benefits of donanemab against the possible risks.
“On a population basis, our view is that the benefits outweigh the risks,” Skovronsky said.
“The FDA is in charge of that for the United States,” he said of the risk-benefit analysis that will determine whether donanemab is approved.
