Leqembi™ Now Approved by FDA for the Treatment of Alzheimer’s Disease

A bi-weekly IV infusion approved through the FDA’s accelerated approval pathway
· 10 min read

After successfully making it through the FDA’s accelerated approval pathway, Eisai/Biogen’s Leqembi™ (lecanemab-irmb) is now available for the treatment of Alzheimer’s Disease (AD), which is currently ranked as the seventh leading cause of death in the U.S. and the most common cause of dementia among older adults.

At this time, the treatment is only approved for patients with mild cognitive impairment or mild dementia. However, this drug is an exciting step for the AD community and the millions of people impacted as it is estimated that more than 6 million Americans may have dementia caused by Alzheimer’s disease.

Leqembi™, administered bi-weekly via IV infusion, works by selectively binding to neutralize and eliminate soluble amyloid-beta (Aβ) plaques that are thought to contribute to the progression of Alzheimer’s disease. Expected to be available by the end of January 2023, the price is estimated at $26,500 per year, which comes in just lower than Biogen’s Aduhelm® (aducanumab) at $28,200 per year.

A third potential treatment from Eli-Lily, Donanemab, was just recently rejected under the FDA’s accelerated pathway due to the limited number of patients included in the clinical study. The company will move forward with a traditional approval filing later this year.

To learn more about Alzheimer’s disease and Leqembi™ click here.

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