Alzheimer’s treatments have experienced a revival, with pharma giant Eli Lilly announcing that its experimental drug donanemab has successfully slowed cognitive and functional decline in patients with early-stage Alzheimer’s. Although neither donanemab nor a similar drug called Leqembi amount to a cure for Alzheimer’s, which affects around 6.5 million Americans, Wall Street analysts estimate that each could generate billions in sales.
Eli Lilly’s Donanemab Drug Trial
Eli Lilly’s trial primarily looked at how its drug would affect patients’ ability to perform daily tasks like driving and making a meal, 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 their rate of decline by 35 percent over 18 months. Nearly half of patients who got donanemab saw no worsening of their Alzheimer’s symptoms after a year of treatment, while 71 percent of patients who got the placebo saw their disease advance. Donanemab works to lower levels of proteins in the brain that are thought to be responsible for the progression of Alzheimer’s, and patients receive it until scans show their brains are clear of those proteins, called beta-amyloid.
Positive Results and Side Effects
The positive results, provided in a press release, come months after Biogen and Eisai’s similar Alzheimer’s drug, Leqembi, received accelerated approval from the US Food and Drug Administration. That drug can moderately slow the progression of Alzheimer’s in people who have the early stages of the disease. Patients and their physicians will have to weigh the drug’s benefits against some serious side effects, including swelling or other abnormalities in the brain, which the trial found. While most cases aren’t serious, Lilly said at least two deaths were linked to these side effects.
Clinicians and analysts will most likely pore over the data on Leqembi and donanemab to suss out the advantages and disadvantages of each drug. Leqembi slowed the rate of cognitive decline in Alzheimer’s patients by 27 percent over 18 months in a late-stage study. By the same measure, known as CDR-SB, donanemab slowed cognitive decline by 36 percent. Lilly is counting on new products like donanemab to help it boost sales, as revenue tumbled 11 percent in the first quarter as sales of the company’s coronavirus-fighting antibody treatment declined. Another new product that could generate significant sales is Lilly’s diabetes drug Mounjaro, as it was recently found that the drug could help patients lose almost 16 percent of their body weight. The company said it planned to ask the FDA to approve the treatment for weight loss.