The U.S. Food and Drug Administration (FDA) has given full approval to Leqembi (lecanemab-irmb), a new drug to treat Alzheimer’s disease. The agency granted accelerated approval in January.
The drug is intended to reduce amyloid plaque, a substance in the brain that has been associated with Alzheimer’s. Scientists tested the drug in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease.
The FDA said patients receiving the treatment had a significant reduction of amyloid beta plaque but patients in the control arm of the studies had no reduction of amyloid beta plaque.
The FDA granted full approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease.
The difference between accelerated and full approval is huge. Under accelerated approval, the drug would not be covered by Medicare and it’s expensive. Now that it has received full approval it could be covered by Medicare, making it available to millions of patients who might benefit from it.
“This 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,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
Potential side effect
Like many medicines, Leqembi is not without risks. The FDA is requiring a warning on the drug’s label saying one potential side-effect is “serious and life-threatening brain edema.”
Other Alzheimer’s drugs have received accelerated approval in recent weeks. In June the FDA granted that status to Eli Lily’s drug donanemab, a therapy that also targets amyloid plaque in the brain.
Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans. The disease slowly destroys memory and thinking skills and eventually, the ability to carry out simple tasks.