The Food and Drug Administration (FDA) on Thursday announced its approval of a new drug designed to slow the progression of Alzheimer’s.
Leqembi became the first Alzheimer’s antibody treatment to get full FDA approval July 6 after it was approved for an Accelerated Approval Pathway by the FDA in January, according to a press release from the FDA. The accelerated pathway allows the FDA to preliminarily approve drugs for serious diseases where there is an unmet need, providing the drugmaker conduct a clinical study of the drug’s efficacy. Lequembi’s efficacy was determined following the results of Study 301 — a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 patients with Alzheimer’s disease, the press release continued.
Today, we converted a treatment indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. https://t.co/Yk1yVorMN6 pic.twitter.com/Gn3VNrmNVf
— U.S. FDA (@US_FDA) July 6, 2023
In the study, Leqembi showed a “statistically significant and clinically meaningful reduction of decline” of the progression of the disease in patients over an 18-month period, according to the release.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the FDA’s Office of Neuroscience, said in the press release. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
Not everyone agrees, however, with some pointing to Leqembi’s notable side effects as too risky to truly benefit patients who are struggling with Alzheimer’s. (RELATED: MIT Scientists Reveal ‘Remarkable’ Breakthrough For Treating Alzheimer’s)
“The odds for brain swelling and hemorrhage are far higher than any actual improvement,” said Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine, according to NBC News. After results of the Study 301 became available, Espay launched a petition in June seeking to prevent the drug’s full approval by the FDA as 12.6% of the trial patients reportedly experienced brain swelling. Further, Espay argued that by slowing the progress of the disease by 27%, Leqembi fails to meet the threshold of what would be considered “noticeable” to a patient, NBC reported.
The FDA, in approving the drug, did affix it with its strongest warning label, known as a boxed warning, which outlines the brain swelling and hemorrhaging experienced by some patients can lead to seizures and death, according to NBC. Prior to taking Leqembi, patients are encouraged to undergo genetic testing to gain a better understanding of the risks they might face before taking the drug.
Although Leqembi is considered a costly drug, coming in at $26,000 a year, its full approval from the FDA will allow 80% to be covered by Medicare, making it more accessible to seniors, according to NBC. The remaining 20% will still cost patients thousands of dollars out-of-pocket, the outlet reported.