If approved, Eli Lilly’s donanemab would become the second Alzheimer’s drug of its kind to enter the market after Leqembi from Biogen and Eisai.
A panel of independent advisors to the FDA recommended Eli Lilly's Alzheimer's drug donanemab, paving the way for the treatment to receive full approval in the U.S. later this year.
In a first vote, 11 committee members unanimously said available data on the drug shows that it is effective at treating Alzheimer's patients at the early stages of the mind-wasting disease. But several advisors noted that more data is needed on donanemab in Black and Hispanic patients, among other groups.
Both drugs are monoclonal antibodies that target amyloid plaque in the brain, considered a hallmark of Alzheimer's, to slow the progression of the disease in patients at the early stages of it.Drugs that target and clear amyloid plaque can also cause brain swelling and bleeding in patients, which in some cases can be severe and even fatal.
Leqembi is currently administered through twice-monthly infusions, but Biogen expects to launch an injectable version of the drug next year, Risinger noted. He expects donanemab to rake in $500 million in sales by the end of the decade.Eli Lilly's phase three trial on more than 1,700 patients found that donanemab slowed the progression of Alzheimer's by 29% compared to a placebo after around 18 months, based on a traditional tool used to measure the severity of dementia.
"From a very practical perspective, I think this would be not a wise thing to to have as a barrier," said temporary committee member Dr. Kathleen Poston, a professor in neurology, neurological sciences and neurosurgery at Stanford University, during the meeting on Monday.
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