FDA Grants Accelerated Approval for New Alzheimer Disease Drug

The US Food and Drug Administration (FDA) granted accelerated approval for lecanemab-irmb for the treatment of Alzheimer disease, according to a press release issued on January 6.

Lecanemab, also known by the branded name Leqembi, is a humanized IgG1 monoclonal antibody developed by Eisai in partnership with Biogen.

More than 6.5 million Americans have Alzheimer disease, an irreversible, progressive disorder that erodes memory and cognitive function. Lecanemab is now the second drug approved in the space which targets the pathophysiology of the disease rather than the symptoms, the press release said.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

The drug’s approval was supported by a placebo-controlled trial in which researchers studied lecanemab’s impact on 856 patients with Alzheimer disease who had mild cognitive impairment or a mild dementia stage. At a dosage of 10 mg/kg administered every 2 weeks, lecanemab was associated with a statistically significant reduction in brain amyloid beta plaque at Week 79, while there was no reduction in the placebo group.

The FDA anticipates receiving data soon from a phase 3 randomized study to confirm the drug’s clinical benefit.

Lecanemab’s most common side effects are infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA).

ARIA presents as temporary swelling in the brain that usually resolves on its own. Patients may also have small spots of bleeding in or on the surface of the brain. ARIA can cause symptoms such as headache, confusion, dizziness, vision changes, nausea, and seizures; serious, life-threatening events are rare.

Lecanemab is only approved for the patient population studied in clinical trials. Per the drug’s label, there are currently no data to support lecanemab’s safety or efficacy if administered at earlier or later stages of the disease.

Reference:
US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s disease treatment. News Release. January 6, 2023. Accessed January 6, 2023. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment