FDA Grant Approval for Alzheimer's Drug Leqembi
In early October, Eisai and Biogen released promising results from Phase III trials for their monoclonal antibody lecanemab, and they moved on to seek regulatory approval. On January 6th, the companies announced that the FDA had cleared the drug under the accelerated approval pathway. It will be sold as “Leqembi” and priced at $26,500 annually.
This approval marks the second approval by the FDA of an anti-amyloid beta antibody; in 2021, Biogen’s Aduhelm was cleared, but the Centers for Medicare & Medicaid Services (CMS) refused to pay the $56,000 price except for use in patients in clinical trials. Moreover, the evidence that Aduhelm actually made any difference for Alzheimer's patients was somewhat ambiguous. Ultimately, there were no marked sales, even when Biogen halved the price. Eisai will take the lead with Leqembi's commercialisation.
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However, existing coverage limitations from CMS mean that many patients again will not have access to Leqembi. Currently, as was the case with Aduhelm, only patients enrolled in clinical trials will have access to the drug. CMS has said it is looking at the available information and may reconsider its current stance.
CMS has also suggested that if Eisai and Biogen can obtain full FDA approval, beyond that which comes with the accelerated pathway, this may lead to broader coverage. Ivan Cheung, Eisai’s US leader and Global Alzheimer’s Chief, said in an interview that full approval should happen in “mere days.” He added that current conversations between the companies and the government bodies were proving to be “very productive,” but equally that they do not expect to see a reversal in CMS’ decision before full approval is granted.
Alongside these discussions over drug availability, many researchers and clinicians are still casting doubt over the Leqembi's impact. Some have described the results from the Phase III trial as “modest,” and many doctors have questioned whether patients would actually notice the drug’s impact since disease progression was only slowed by 27% over 18 months. Nonetheless, it is hard to argue that Leqembi is a step in the right direction for a field that has long lacked what Cheung termed a “foundational spark” to lead the way to more significant discoveries.
In the meantime, approval filings in other countries are still underway; those made in Japan and the EU are expected to receive responses by the end of March, and an application was filed in China in December. Applications in Australia, Canada, the UK, and Switzerland are also on the horizon, and it seems like it is simply a matter of time before more approvals are announced.
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