The drug is expected to be cleared by the end of the first quarter of this year, after the expected approval was already pushed back. last year. It follows Eisai and Biogen For the dresser Marketing it as the second drug to slow down the memory-debilitating disease that affects more than 6 million Americans. Both drugs work by targeting plaque deposits known as amyloid in the brain.
The FDA told Lilly it plans to convene an advisory meeting called Trailblazer-Alz 2 to review donamab’s safety as well as design a key clinical trial to support its application, the company said in a news release Friday. A date for the meeting has not been set, Lilly said.
“We are confident that donamab will provide significant benefits to people with early symptomatic Alzheimer’s disease,” said Ann White, president of Lilly Neuroscience. “It was unexpected that the FDA would convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the Trailblazer-Alz 2 results and put donanemab’s strong efficacy in a safety context.”
The main safety concerns of these drugs are brain swelling and micro-hemorrhages known as amyloid-related imaging abnormalities or ARIA. Donamab phase 3 clinical Experiment37% of participants had ARIA, including three who died.
He has been a composer Arrested Although the rate of ARIA is low, so is patient mortality Experiments.
Lilly also wants the FDA to weigh in on the “unique trial design” of the donanemab study, which allowed the outside experts to stop taking the drug after showing that amyloid plaques were cleared from the brain. Other Alzheimer’s drugs, including Lexambi, do not have stopping points.
The trial was also different in that it separated patients into groups based on levels of another Alzheimer’s-related protein called tau. Among participants known to have “moderate” tau levels, those taking donamab had a 35 percent slower decline in their ability to think clearly and perform daily tasks compared to those taking a placebo.
When people with high levels of tau – thought to be living with the disease – were included, the benefit compared to placebo was 22%.
LeKambi received full approval from the FDA in July, a decision that triggered broader Medicare coverage. But the drug has gotten off to a slow start, with only about 2,000 people taking it, Biogen said on its quarterly earnings call Feb. 13, which it said may reflect the challenges of these drugs, which require multiple scans and tests before they start. And throughout the treatment.
The FDA has had a troubled history with recent Alzheimer’s drug approvals. He It has been cleared In 2021, against advice from an advisory panel and the Centers for Medicare and Medicaid Services, a prodrug called Aduhelmin was approved. Limited coverage For medicine, noting that there is no evidence behind it. The drug was never taken, and Biogen It has been discontinued It’s in January.