U.S. FDA Gives Green Light to Leqembi, aka Lecanemab

The Food and Drug Administration today approved Eisai’s anti-amyloid antibody lecanemab, now called Leqembi, via its accelerated approval pathway. The decision was widely expected based on the positive Phase 2 and 3 results for lecanemab, and because of a similar accelerated approval previously for aducanumab in 2021 (Jun 2021 news; Sep 2022 news; Dec 2022 conference news).

  • The FDA granted accelerated approval to Eisai’s lecanemab for AD.
  • The agency urged caution when prescribing for people on blood thinners.
  • Eisai set the price at $26,500 per year.

Advocacy groups welcomed the move, and many physicians are likely to prescribe the drug for certain patients. Media coverage was positive overall, while noting limitations such as the small clinical effect (see The Washington Post; The New York Times).

Unlike the initially broad label granted aducanumab, lecanemab’s FDA label restricts use to people with evidence of amyloid plaque buildup and mild cognitive impairment or mild dementia. This is the same population studied in the clinical trials, and is estimated to comprise 1 million people in the U.S., or about 20 percent of those with AD (STAT news).

The FDA label warns about the risk of infusion-related reactions and the brain edema and microhemorrhages known as ARIA. In particular, the label urges caution when prescribing lecanemab to people on blood thinners. Blood thinners recently have been associated with three deaths in the Phase 3 open-label extension trial (see related story). However, the label does not specify contraindications, nor require a Risk Evaluation and Mitigation Strategy (REMS), which is used with some risky medications. To monitor for ARIA, three MRI scans should be administered within a person’s first 14 weeks on drug, the FDA said. For its part, Eisai has committed to running programs to train physicians how to detect and monitor ARIA.

Eisai acknowledged that initial uptake of lecanemab is likely to be slow, given that last year the Centers for Medicare and Medicaid Services limited coverage for this class of drugs to clinical trials (Apr 2022 news). In that decision, CMS promised to swiftly reconsider their stance based on new evidence. The Alzheimer’s Association has filed a formal request for CMS to issue a revised National Coverage Determination. Meanwhile, Eisai’s global AD leader Ivan Cheung has said the company is in discussions with CMS regarding coverage (Endpoints News).

Without insurance coverage, few patients will be able to afford the drug. Eisai has set its price at $26,500 per year, half of aducanumab’s initial $56,000 per year, and slightly lower than aducanumab’s revised price of $28,800. In December, the Institute for Clinical and Economic Review, in a draft analysis, called $8,500 to $20,500 per year justified based on demonstrated clinical benefits. A 2020 survey of 25 insurers and 120 neurologists conducted by Biogen cited consensus that amyloid immunotherapy should cost below $30,000, and ideally less than $20,000 annually, to maximize the number of people who receive the treatment (STAT news). Cheung noted that lecanemab’s cost will go down to about $15,000 per year in the lower-dosing maintenance phase once amyloid is cleared (Mar 2022 conference news).

Eisai’s partner Biogen will produce lecanemab at its factory in Solothurn, Switzerland, and will co-market the drug. Eisai plans to file for approval in Japan and the European Union by the end of March, and soon after in Australia, Canada, China, Switzerland, and the U.K. The company expects a slow rollout, with perhaps 100,000 people taking the drug after three years.

Oh, and the new name? “Leqembi” was chosen to reflect lecanemab’s origins, according to Eisai. The L honors Lars Lannfelt, who first developed the antibody at BioArctic; the E stands for Eisai; and “qembi” comes from the company’s native Japanese language, meaning healthy or beautiful.—Madolyn Bowman Rogers

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References

Therapeutics Citations

  1. Aduhelm

News Citations

  1. Aducanumab Approved to Treat Alzheimer’s Disease
  2. Finally: Big Win on All Outcomes for Lecanemab in Phase 3 Topline Results
  3. Dare We Say Consensus Achieved: Lecanemab Slows the Disease
  4. Should People on Blood Thinners Forego Leqembi?
  5. Drilling Down into the CMS Aduhelm Decision—A Primer
  6. Using Lecanemab Trial Data to Determine Maintenance Dose

Other Citations

  1. lecanemab

External Citations

  1. approved
  2. The Washington Post
  3. The New York Times
  4. STAT news)
  5. Risk Evaluation and Mitigation Strategy
  6. formal request
  7. Endpoints News
  8. draft analysis
  9. STAT news

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