Update: On 6 March, Eisai confirmed in a press release that the United States Food and Drug Administration (FDA) had accepted an application for lecanemab (Brand Name: Leqembi) to be considered under priority review for its conversion from accelerated approval to traditional approval.
The assessment of data from a confirmatory trial is a necessary step to ensure that Leqembi can remain on the market in the US.
The FDA is expected to make its decision no later than the 6 July 2023. Should Leqembi receive traditional approval, it will be the first time that an antibody treatment for Alzheimer’s disease has received traditional approval from the FDA.
On 6 January, the United States FDA approved lecanemab for those living with dementia with mild cognitive impairment or mild dementia, the population on which the treatment was studied in clinical trials.
This is the second Alzheimer’s disease treatment to be approved in the US since 2003 after approval of aducanumab (Aduhelm) last year.
In a statement released on their website, the FDA stated:
“Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease.”
This news comes following the publication of the results of the Phase 3 study for lecanemab entitled CLARITY AD which suggested that lecanemab had significant therapeutic efficacy in reducing cognitive decline, the primary endpoint for the trial.
Biogen and Eisai have indicated that they will seek regulatory approval in Japan and Europe before the end of March 2023.
In response to the news, ADI CEO Paola Barbarino said:
We are delighted with the news that a new treatment for Alzheimer’s disease will soon be available to those living with Alzheimer’s disease in the United States and hope that Eisai and Biogen will do all that they can to expedite its availability in other countries across the globe, noting their imminent plans to file marketing authorization applications for Japan and Europe. We urge regulatory authorities to consider this treatment using the same parameters as they would with other conditions and to avoid the stigma, ageism and discrimination that is often associated with the condition.
As with other approved treatments and for those in development, the approval of lecanemab further highlights the necessity to address health system readiness across the globe, and accordingly raises important questions relating to the availability of the treatment, access, eligibility and affordability for those living with dementia in markets where there are no imminent plans to file regulatory approval or for countries where health systems are still being developed, especially those in low and middle income countries.
Chair of ADI’s Medical and Scientific Panel (MSAP), Alireza Atri said: “The process for lecanemab to eventually be widely accessible and therapeutically optimised as a clinical standard care option will take years of multi-stakeholder collaboration, commitment, alignment, thoughtfulness, time and effort. In the United States, over the next year and more, it will require full FDA approval; scientifically-based, equitable and accessible coverage determinations; practical appropriate use recommendations to further guide clinicians in the safe and effective use of a novel class of and paradigm for AD therapeutics; and surmounting many knowledge, proficiency, resource and systemic challenges.”
Nonetheless, these are not simply aspirational but are achievable and an imperative in order to advance along the path of bringing better therapeutic choices for the benefit of our patients and families impacted by Alzheimer’s disease.
ADI will provide further updates as and when they are available, in particular with regard to reimbursement of this medication by healthcare authorities and possible inequalities.