FDA approves Leqembi for Alzheimer’s disease
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The FDA has granted Eisai full approval for Leqembi to treat adults with Alzheimer’s disease.
According to a press release from the regulatory agency, Leqembi (lecanemab, Eisai/Biogen) is the first amyloid-targeting antibody to be granted traditional approval after receiving accelerated approval.
“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 Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, stated in the release. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
A humanized immunoglobulin gamma 1 monoclonal antibody that clears amyloid beta and removes amyloid plaques in the brain, Leqembi was approved as a 100 mg/mL IV dose and indicated for those with mild cognitive impairment or the mild dementia stage of AD.
"Alzheimer's disease is a progressive, fatal disease that greatly impacts not only the people living with it, but also their loved ones, care partners and society,” Eisai CEO Haruo Naito, said in a joint press release from Eisai and Biogen.
Expressing his gratitude to those who have worked exhaustively towards an effective treatment for AD, Biogen President and CEO Christopher Viehbacher stated, “Today marks a breakthrough in the treatment of Alzheimer's disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable.”
In early June, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously ruled that Leqembi showed clinical benefit in early AD, roughly 5 months after the therapeutic was granted accelerated approval based on results of the CLARITY AD study, a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial.
"Approval of Leqembi will serve as a catalyst for driving further developments and investments in the Alzheimer’s pipeline,” Howard Fillit, MD, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said in a foundation press release. “It is more important than ever to double down and widen our focus to developing the next generation of drugs based on the biology of aging that can lead to a combination therapy and precision medicine approach.”
Editor’s note: This article was updated July 7, 2023, to add information on the dosage of Leqembi as well as comments from Eisai and Biogen executives.
Perspective
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Rajesh R. Tampi, MD, MS, DFAPA, DFAAGP
The traditional approval of Leqembi by the FDA is a big step in finding effective treatments for Alzheimer’s disease. Lecanemab-irmb becomes the first drug in its class to receive a traditional approval from the FDA. This approval process of lecanemab-irmb and the announcement by CMS confirming a broader coverage for the drug is great news for individuals with AD and their family members. This drug will now be more widely available for use among people with AD who desperately need more effective treatments. The traditional approval of lecanemab-irmb will also serve as a catalyst for pharmaceutical companies to invest in trials of newer classes of medications in order to find more effective treatments for a devastating illness like AD.
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