An experimental drug for Alzheimer’s disease has hit a major roadblock, moving it closer to approval.
Pharmaceutical giant Eli Lilly said donanemab slowed cognitive decline in people with Alzheimer’s.
The news comes months after the FDA approved an Alzheimer’s drug called Leqembi.
After years of stagnation, treatments for Alzheimer’s are experiencing a renaissance.
On Wednesday, pharmaceutical giant Eli Lilly said its experimental drug donanemab was successful in slowing cognitive and functional decline in patients with early-stage Alzheimer’s, offering hope for people with the condition who lack good treatment options. . Lilly said it would submit the data to US regulators before the end of June and hoped to win approval by the first half of next year.
The positive results, provided in a press release, come months after an Alzheimer’s-like drug from Biogen and Eisai, called Leqembi, received accelerated approval from the US Food and Drug Administration. That drug can moderately slow the progression of Alzheimer’s in people with the early stages of the disease.
New Alzheimer’s treatments could generate billions in sales by slowing the disease
Neither drug is a cure for Alzheimer’s, which affects about 6.5 million Americans. Still, Wall Street analysts estimate that each could generate billions in sales. Jefferies, for example, said in a March 13 note that donanemab could bring in $7.5 billion a year for Lilly at its peak. Lilly’s stock jumped 8.8% in early trading on Wednesday, after the results were announced.
Eli Lilly’s trial looked primarily at how its drug would affect patients’ ability to perform everyday tasks such as driving and eating, as measured by the integrated Alzheimer’s Disease Rating Scale, or iADRS. By that measure, the late-stage trial, which included 1,182 participants, slowed its rate of decline by 35% over 18 months. Lilly said they planned to submit the findings for publication in a peer-reviewed journal.
“This is the first Phase III trial of any investigational medicine in Alzheimer’s disease to deliver a 35% clinical and functional remission,” said Dawn Brooks, the global development leader who oversees donanemab, in an interview.
“This exceeds what we have seen in the field so far,” Brooks added. “Less progress means more time for patients.”
Weighing the benefits and side effects of donanemab
In the trial, almost half of the patients who received donanemab saw no worsening of their Alzheimer’s symptoms after a year of treatment, while 71% of patients who received the placebo saw their disease progress.
“We want more time to remember more things. And so I think that the concept of time is kind of universal and helpful to express clinical meaning,” said Dr. John Sims, head of donanemab medicine, Insider.
Patients and their physicians will have to weigh the benefits of the drug against some serious side effects. The trial found that taking the drug could lead to cases of swelling or other abnormalities in the brain. Although most cases are not serious, Lilly said at least two deaths have been linked to these side effects.
Donanemab, like Leqembi, works to lower levels of proteins in the brain thought to be responsible for the progression of Alzheimer’s. In the trial, patients received donanemab until scans showed their brains were clear of those proteins, called beta-amyloid. On the other hand, it is planned to give Leqembi for a longer period of time. Both are given by IV, with donanemab administered every four weeks and Leqembi every two weeks.
Comparing Alzheimer’s treatments
Clinicians and analysts are more likely to look beyond the data on Leqembi and donanemab to determine the pros and cons of each drug. Leqembi slowed the rate of cognitive decline in Alzheimer’s patients by 27% over 18 months in a late study. Under the same measure, called CDR-SB, donanemab slowed cognitive decline by 36%.
SVB Securities analysts said in an April 16 note that if donanemab showed “significantly better efficacy” compared to Leqembi, meaning a 35% slowdown as measured by CDR-SB, they expected Eli Lilly’s shares to jump.
Sims said that because patients receive donanemab for a set period of time, that would help reduce the burden for many patients.
“I think that will be an attractive feature for people,” he said. “What we’re excited about now is that we hope there will be multiple options for patients.”
New products could boost Eli Lilly
Currently, Leqembi is not covered by the US government’s Medicare program, making it difficult for patients to receive the treatment. That could change if the drug receives full approval from the FDA, which could happen as early as July.
Another high-profile drug for Alzheimer’s received accelerated approval in 2021 but has languished commercially because of mixed data on whether it actually helps patients. That drug, Aduhelm, was also developed by Eisai and Biogen.
Lilly is counting on new products like donanemab to help it grow sales. Revenue fell 11% in the first quarter as sales of the company’s antibody treatment to fight the coronavirus declined. Another new product that could generate significant sales is Lilly’s diabetes drug, Mounjaro. The company recently published data showing the drug could help patients lose nearly 16% of their body weight and said it planned to ask the FDA to approve the treatment for weight loss.
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