Eli Lilly’s treatment with solanezumab failed to slow the disease

Eli Lilly on Wednesday said it would halt development of its Alzheimer’s drug candidate solanezumab after the antibody failed to slow the progression of the disease.

The failure of solanezumab has dealt a blow to efforts to treat Alzheimer’s disease in people who are at a very early stage of the disease and not yet showing clinical symptoms.

The study involved more than 1,000 elderly people with normal memory and thinking, but with signs of brain plaques associated with Alzheimer’s disease.

Solanezumab did not clear or stop the buildup of plaques called amyloids or slow cognitive decline in treated participants.

“These data suggest that we may need to remove amyloid more aggressively even at this very early stage of the disease,” the doctor said. Reisa Sperling, neurologist at Brigham and Women’s Hospital and leader of the study.

Solanezumab was developed to target plaque floating in the brain. Lilly is developing two other Alzheimer’s drugs that are in the final stages of clinical trials: donanemab and remternetug. These antibodies target plaques deposited in the brain and are intended to treat people with early symptoms of the disease.

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Lilly plans to release data from clinical trials of donanemab in the second quarter of this year. The company plans to ask the Food and Drug Administration to approve the treatment if the data is positive.

Lilly applied to the FDA for an expedited approval of donanemab, but the agency denied the company’s request in January. The agency told Lilly that it needed to provide data on at least 100 patients treated over a 12-month period.

Lilly said she doesn’t have that date because donanemab quickly clears plaque from the brains of many patients.

“Because of the rate of plaque reduction we observed, many patients were able to stop taking donanemab as early as six months after starting treatment, resulting in fewer patients receiving a donanemab dose for 12 months or more,” says Dr. This was announced to analysts by Lilly chief scientist Dan Skowronski during the company’s earnings report in February.

“We remain confident in the potential of donanemab as a novel treatment for people with early symptomatic Alzheimer’s disease,” Skowronski said.

In January, the Food and Drug Administration (FDA) approved Eisai and Biogen’s fast-track drug Lekambi for the early treatment of Alzheimer’s disease. The companies expect the agency to make a decision on full approval in July.

Medicare will only cover Alzheimer’s antibody drugs that have received fast-track approval for people in clinical trials. The National Health Insurance Program for the Elderly has said it will provide broader coverage once the FDA gives full approval.

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