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Eli Lilly Alzheimer’s treatment solenzumab fails to slow disease progression

HealthHealth CareEli Lilly Alzheimer's treatment solenzumab fails to slow disease progression
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Eli Lilly on Wednesday said it would halt development of Alzheimer’s treatment candidate solenzumab after the antibody failed to slow the progression of the disease.

The failure of solenzumab is a setback for efforts to treat Alzheimer’s in people who are in the early stages of the disease and have not yet shown clinical symptoms.

The study enrolled more than 1,000 seniors who had normal memory and thinking abilities but showed signs of brain plaques associated with Alzheimer’s.

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Solanezumab did not clear or prevent the accumulation of plaques called amyloid, and did not slow cognitive decline in participants who received the treatment.

“These data suggest that we may need to be more aggressive with amyloid removal even at this early stage of the disease,” said Dr. Risa Sperling, a neurologist at Brigham and Women’s Hospital and director of the study.

Solenzumab was designed to target the plaque that floats in the brain. Lilly is developing two other Alzheimer’s treatments that are in late-stage clinical trials, donnemab and remternetag. These antibodies target plaque that has accumulated on the brain and are designed to treat people who have early symptoms of the disease.

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Lilly expects to publish clinical trial data on donanumab in the second quarter of this year. If the data is positive, the company plans to ask the Food and Drug Administration to approve the treatment.

Lilly had asked the FDA for expedited approval of donanemab, but the agency rejected the company’s request in January. The agency told Lilly that it would need to submit data on at least 100 patients who took the treatment for 12 months.

Lilly said she didn’t have that data because donanumab quickly cleared brain plaque in many patients.

Dr. Dan Skowronsky, Lilly’s chief scientific officer, said, “We saw that because of the speed of plaque reduction, many patients were able to discontinue dosing within six months of treatment, resulting in fewer patients living for 12 months or more.” Doses of donenumab were being received.” , told analysts during the company’s earnings call in February.

“We are convinced of the potential of danimumab as a new treatment for people with early signs of Alzheimer’s disease,” Skowronsky said.

The FDA approved Eisai’s and Biogen’s early Alzheimer’s treatment Leqembi on an expedited 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 early approval for people participating in clinical trials. The public health insurance program for seniors said it would provide comprehensive coverage as soon as the FDA grants full approval.

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