Lecanemab: FDA Set Accelerated Approval Decision for January 2023

While the field awaits Phase 3 data on Eisai and Biogen’s anti-amyloid antibody lecanemab, the drug’s application for accelerated approval based on Phase 2 biomarker data continues to wend its way through the regulatory system. On July 5, the U.S. Food and Drug Administration formally accepted the companies' Biologics License Application (BLA) for lecanemab, granting it priority review. This means the agency will make a final decision within six months, by January 6, 2023.

Lecanemab, aka BAN2401, follows the path established by aducanumab, which received accelerated approval last year (Jun 2021 news). On the heels of that approval, the FDA granted lecanemab breakthrough therapy status, a designation that speeds the regulatory process and allows companies to submit data as they acquire it.

Eisai/Biogen began such a rolling submission for lecanemab in September 2021, completing it this May (Oct 2021 news; May 2022 news). The submission rests on Phase 2 data showing robust plaque clearance plus a modest slowing of cognitive decline (Jul 2018 news; Nov 2018 news; Swanson et al., 2021).

Meanwhile, the Phase 3 Clarity trial of lecanemab is expected to read out this fall (Nov 2020 conference news). If the findings are positive, the companies will submit an application to the FDA for traditional approval by the end of March 2023, and will also apply for approval in Japan and Europe, according to an Eisai press release.

Lecanemab is also being evaluated in the AHEAD 3-45 secondary prevention trial, as well as the DIAN-TU Tau NexGen trial, which tests amyloid and tau therapies given together (Nov 2021 conference news).—Madolyn Bowman Rogers

Comments

  1. One has to give Esai and Biogen some credit for persistence in seeking FDA approval for their anti-amyloid antibody, lecanemab. Hopefully, some lessons have been learned from the wreckage of the earlier Aduhelm approval travails.

    Excessive coziness with FDA staff may trigger an ethics blowup. Mathematics and statistics agreement within the FDA staff will be desirable. If an entire advisory panel objects and some resign, something is wrong somewhere. Several support letters from Alzheimer's advocacy groups followed significant manufacturer contributions to them, and merely parroted the drug companies' lines. They showed no independent analysis of the evidence. Various stealth operations obviously conducted through intermediaries provided a pejorative tinge. Finally, waste no more space on declaring an efficacious drug is needed; everybody admits that. But that is no reason to approve a clunker.

    View all comments by Leslie Norins

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References

Therapeutics Citations

  1. Leqembi

News Citations

  1. Aducanumab Approved to Treat Alzheimer’s Disease
  2. Lecanemab Follows Aduhelm’s Path to Accelerated Approval
  3. With Aduhelm in Retrenchment, Lecanemab Completes FDA Submission
  4. BAN2401 Removes Brain Amyloid, Possibly Slows Cognitive Decline
  5. Second Look at BAN2401 Data Still Positive, Despite Snafu
  6. BAN2401 Forges AHEAD into Phase 3, Preclinical AD
  7. Lecanemab Sweeps Up Toxic Aβ Protofibrils, Catches Eyes of Trialists

Paper Citations

  1. Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RY, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. PubMed. Correction.

External Citations

  1. Eisai press release

Further Reading

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