Eli Lilly’s treatment solanezumab failed to slow the disease
The Eli Lilly logo is seen at one of the company’s offices in San Diego, California, on September 1[ads1]7, 2020.
Mike Blake | Reuters
Eli Lilly said Wednesday it will halt development of its Alzheimer’s treatment candidate solanezumab after the antibody failed to slow the disease’s progression.
Solanezumab’s failure is a blow to efforts to treat Alzheimer’s in people who are in the very early stages of the disease and have not yet shown clinical symptoms.
The study enrolled more than 1,000 elderly people who had normal memory and thinking but showed signs of brain plaques associated with Alzheimer’s.
Solanezumab did not remove or stop accumulation of the plaque, called amyloid, and did not slow cognitive decline in the participants who received the treatment.
“These data suggest that we may need to be more aggressive with amyloid removal even at this very early stage of the disease,” said Dr. Reisa Sperling, a neurologist at Brigham and Women’s Hospital and director of the study.
Solanezumab was designed to target plaques that float in the brain. Lilly is developing two other Alzheimer’s treatments that are in late-stage clinical trials, donanemab and remternetug. These antibodies target plaque that has built up on the brain and are designed to treat people who have early symptoms of the disease.
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Lilly expects to publish data from clinical trials on donanemab in the second quarter of this year. The company plans to ask the Food and Drug Administration to approve the treatment if these data are positive.
Lilly had asked the FDA for fast-track approval of donanemab, but the agency rejected the company’s request in January. The agency told Lilly it must submit data on at least 100 patients who received the treatment for 12 months.
Lilly said it did not have these data because donanemab cleared brain plaques quickly in many patients.
“Because of the rate of plaque reduction that we saw, many patients were able to stop dosing as early as six months after treatment, resulting in fewer patients receiving 12 months or more of donanemab dosing,” Dr. Dan Skovronsky, Lilly’s chief scientific officer. , analysts said during the company’s earnings call in February.
“We remain confident in the potential of donanemab as a new treatment for people with early symptomatic Alzheimer’s disease,” Skovronsky said.
The FDA approved Eisai’s and Biogen’s early Alzheimer’s treatment Leqembi on an accelerated basis in January. The companies expect the agency to make a decision on full approval in July.
Medicare will only cover Alzheimer’s antibody drugs that receive accelerated approval for people participating in clinical trials. The public health insurance program for seniors said it will provide broader coverage as soon as the FDA gives full approval.