An indication with the corporate logo sits outside of the headquarters campus of Eli Lilly and Company on March 17, 2024 in Indianapolis, Indiana.
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The Food and Drug Administration on Tuesday approved Eli Lilly‘s Alzheimer’s drug donanemab, expanding the limited treatment options for the mind-wasting disease within the U.S.
The agency approved the treatment, which shall be sold under the brand name Kisunla, for adults with early symptomatic Alzheimer’s disease, in keeping with the corporate.
Nearly 7 million Americans have the condition, the fifth-leading reason for death for adults over 65, in keeping with the Alzheimer’s Association. By 2050, that group is projected to rise to almost 13 million within the U.S.
“That is real progress. Today’s approval allows people more options and greater opportunity to have more time,” said Joanne Pike, president and CEO of the Alzheimer’s Association. “Having multiple treatment options is the sort of advancement we have all been waiting for — all of us who’ve been touched, even blindsided, by this difficult and devastating disease.”
It is a long-awaited win for Eli Lilly after donanemab faced obstacles in its path to market. The FDA rejected the drug’s approval last yr as a result of insufficient data, then surprisingly delayed it again in March. Last month, an advisory panel to the agency really helpful the treatment for full approval, saying the advantages outweigh its risks.
A vial of Eli Lilly’s Alzheimer’s drug sold under the brand name Kisunla.
Source: Eli Lilly
Donanemab will compete head-to-head with one other treatment from Biogen and its Japanese partner Eisai called Leqembi, which has regularly rolled out within the U.S. because it won approval last summer.
Donanemab and Leqembi are milestones within the treatment of Alzheimer’s after three a long time of failed efforts to develop medicines that may fight the fatal disease. Each drugs are monoclonal antibodies that concentrate on toxic plaques within the brain called amyloid, an indicator of Alzheimer’s, to slow the progression of the disease in patients on the early stages of it.
Eli Lilly’s drug slowed Alzheimer’s progression by 35% over 18 months compared with a placebo, in keeping with a late-stage trial. Patients were in a position to end their treatment and switch to a placebo after six, 12 or 18 months after they hit certain goals for amyloid plaque clearance.
The drug, which is run through monthly infusions, will cost an estimated $12,522 for a six-month course, $32,000 for 12 months and $48,696 for 18 months. Medicare coverage and reimbursement is out there for eligible patients, Eli Lilly said.
Neither treatment is a cure. Drugs that concentrate on and clear amyloid plaque also can have significant safety risks, including swelling and bleeding within the brain that may be severe and even fatal in some cases.
Three patients who took Eli Lilly’s drug in a late-stage trial died from severe types of those uncomfortable side effects, called amyloid-related imaging abnormalities, or ARIA.
Eli Lilly’s drug is now the third of its kind to succeed in the market after Leqembi and an ill-fated therapy from Biogen and Eisai called Aduhelm. The 2 corporations recently dropped that medicine. The FDA received criticism for its expedited approval of Aduhelm in 2021 despite a negative advice from an advisory panel.
