A medicine for Alzheimer’s of Eli Lilly won the backing of US federal health advisors, paving the way for its long-awaited approval to treat people with mild dementia caused by the neurodegenerative disease.
The advisors of the Food and Drug Administration (FDA) voted unanimously that the drug’s benefits in slowing the progression of the disease outweigh its risks, including side effects such as brain swelling and bleeding, which will need to be monitored.
Upon approval, The shares of the pharmaceutical giant climb more than 2% this Tuesday. Thus, the share papers accumulate 4.6% in the last five days and that gain scales to 13.8% in the last 30 days.
“I thought the evidence was very strong in the trial showing the effectiveness of the drug,” said panel member Dean Follmann, a statistician at the National Institutes of Health.
What will happen to the medicine
The FDA will make a final decision on approval later this year. If the agency follows the panel’s recommendation, the drug donanemab would be only the second drug against Alzheimer’s approved in the United States that has been convincingly shown to slow cognitive decline and memory problems caused by Alzheimer’s. Last year, the FDA approved Leqembi, a similar infusion drug from Japanese pharmaceutical company Eisai.
The slowdown seen with both drugs is several months, and experts disagree on whether patients or their loved ones will notice the difference.
The approach of Lilly studying its monthly treatment raised questions from FDA reviewers. Patients in the company’s study were grouped according to their levels of a brain protein called tau, which predicts the severity of cognitive problems.
This led to the FDA to question whether patients would need to be screened by brain scans for tau before receiving the drug. However, most panelists felt there was enough evidence of the drug’s benefit to prescribe it widely without performing these tests.
“Imposing a requirement for tau imaging is not necessary and would raise serious practical and treatment access concerns,” said Dr. Thomas Montine of Stanford University, who chaired the panel and summarized his opinion.
Alzheimer’s
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Overall, Lilly’s results mirrored Leqembi’s, with both drugs showing a modest slowing of cognitive problems in patients with AAlzheimer’s in early stage. Lilly conducted a study with 1,700 patients that showed that those who received monthly intravenous infusions of their medication experienced a decline in cognitive decline about 35% slower than those who received a placebo.
The FDA was expected to approve the drug in March. However, the agency instead decided to ask its panel of neurology experts to publicly review the company’s data, an unexpected delay that surprised analysts and investors.
Some unusual approaches in the way Lilly tested its drug led to the meeting. One change was to measure patients’ tau and exclude those with very low or no levels of the protein. But the panelists said there was enough data from other measures to feel confident that almost all patients could benefit from the drug, regardless of their tau levels.
The FDA panel agreed that those risks could be addressed through warning labels and education for doctors, as well as medical screening to identify patients at highest risk for stroke.
