Leqembi (lecanemab) Receives Full FDA Approval

Jul 27, 2023

For years, researchers have been working to develop therapies that alleviate the symptoms, and slow the progression, of Alzheimer’s disease.

Recently, a first-of-its kind treatment received FDA approval to do just that. Here’s what you need to know:

What has the FDA said?

On January 6, 2023, the FDA granted Eisai Co. and Biogen Inc.’s’ Leqembi (lecanemab) accelerated approval for Alzheimer’s patients with mild cognitive impairment or mild dementia. It was stipulated that continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

As of July 6, the FDA has given full approval after verifying Leqembi’s clinical benefit.

How does Leqembi work?

Leqembi reduces the buildup of amyloid plaques in the brain of patients with Alzheimer’s and has displayed a 27% reduction in clinical decline compared to placebo at 18 months. This is particularly significant due to the lack of treatment alternatives in the Alzheimer’s disease space.

What do we need to know about Leqembi’s safety?

Prior to initial administration of Leqembi, the presence of amyloid beta plaques must be confirmed in Alzheimer’s patients experiencing mild cognitive impairment or mild dementia. Amyloid-related imaging abnormalities (ARIA) have been observed with monoclonal antibody therapies like Leqeumbi. While ARIA is usually asymptomatic, in rare cases, it could be serious and life-threatening. A boxed warning has been included in the label for Leqembi to call attention to these potential risks.

How is Leqembi administered?

The recommended dosage of Leqembi is 10 mg/kg given as IV infusion every two weeks with an estimated cost ranging from $25,000-$26,500 per year.

What comes next?

The approval of Leqembi represents a significant milestone in Alzheimer’s research and treatment. As research and development continue, this approval may pave the way for even more advanced therapies and preventative measures.

The traditional/full approval by the FDA also opens the door for broader coverage of the drug. And the Centers for Medicare and Medicaid Services (CMS) has already indicated that Medicare will cover Leqembi for patients with early signs of cognitive decline and elevated amyloid in appropriate settings.

At Abarca, we celebrate the approval of this innovative treatment and are committed to ensuring patients have access to medications that have been proven effective and safe for their unique situation.

We will continue to monitor the evidence of this therapy as we work to provide a seamless and personalized healthcare experience for everyone.


*This blog was written by Brock Bizzell, PharmD, MBA, BCPS, Manager-Pharmacy Programs at Abarca Health, LLC.


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