With Aduhelm in Retrenchment, Lecanemab Completes FDA Submission

Last months' decision by the U.S. Centers for Medicare and Medicaid Services to deny widespread coverage for aducanumab continues to reverberate (Apr 2022 news). As private insurers follow suit, Biogen announced in a quarterly earnings report its plans to lay off personnel in its aducanumab commercial group, and reported other cost-cutting measures as well as the departure of CEO Michel Vounatsos (Endpoints news).

“I am sad to say that Aduhelm's future is in peril given the restrictions by the CMS,” Marwan Sabbagh at the Barrow Neurological Institute in Phoenix told Alzforum. “The logical way forward for the field, and Biogen for that matter, is to do another blinded RCT.”

Biogen affirmed that it will continue ENVISION, a Phase 4 confirmatory trial that is supposed to start enrolling this month, as well as EMBARK, the ongoing open-label extension of prior Phase 3 trials. “Biogen expects to continue funding certain regulatory and R&D activities for Aduhelm,” the quarterly report noted. It also states that, “Additional actions regarding Aduhelm may be informed by upcoming data readouts expected for this class of antibodies, as well as further engagement with the FDA and CMS.”

It is unclear if the 6,000-patient International Collaboration for Real-World Evidence in Alzheimer’s Disease post-market study will continue. Biogen representatives told Alzforum they were not yet ready to make an announcement on iCARE (Aug 2021 news). Only a small number of patients nationwide, perhaps in the hundreds, are currently taking aducanumab outside of a trial setting. Biogen committed to continuing to provide the drug for free to this group, but new patients interested in the treatment will likely have to pay out of pocket.

Biogen did not respond to queries asking whether a small Phase 1 study of subcutaneous aducanumab would continue. However, representatives at Eli Lilly told Alzforum they would continue their head-to-head study of aducanumab and donanemab, for which topline results are expected by the end of the year. “Patients were excited to enroll in this trial, given the opportunity to be on active drug in both arms,” the company noted in an email. “We have the opportunity for continued learning for the field, including whether more quickly lowering plaque translates to a benefit on tau and GFAP [biomarkers].”

Meanwhile, Eisai announced that it and partner Biogen have completed their biologics license application for lecanemab to the FDA under the agency's accelerated approval pathway, and have requested priority review. Results of lecanemab's Phase 3 study are due this fall. If they are positive, the companies will request full approval from the FDA in early 2023, and will also submit in Japan, according to Eisai's quarterly report.—Madolyn Bowman Rogers

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References

Therapeutics Citations

  1. Aduhelm
  2. Donanemab
  3. Leqembi

News Citations

  1. Drilling Down into the CMS Aduhelm Decision—A Primer
  2. Seeking Real-World Data on Whether Aducanumab Works

External Citations

  1. quarterly earnings report
  2. Endpoints news
  3. Phase 1 study
  4. study 

Further Reading

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