Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration (FDA) accepted a biologics licence application (BLA) for a subcutaneous version of the drug.
The agency has set a Prescription Drug User Fee Act (PDUFA) action date for the weekly autoinjector form of Leqembi for 31 August 2025.
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Eisai and Biogen’s antibody is currently infused every two weeks in patients with mild cognitive impairment or are in the mild dementia stage of Alzheimer’s, also referred to as early Alzheimer’s.
An under-the-skin formulation would make it simpler and easier for patients and care partners to administer the therapy, along with reducing visits to hospital or infusion sites. The subcutaneous autoinjector dosing, which would also take far less time than an infusion, would provide weekly maintenance for patients who have completed the biweekly intravenous initiation phase.
Eisai and Biogen based the BLA on data from the Clarity AD trial (NCT03887455) and modelling of observed data. The open-label extension trial showed that the subcutaneous form of Leqembi cleared 14% more amyloid plaque in the brain than the infused version in 71 patients who had not received the drug before. The drug works by targeting the buildup of amyloid plaques in the brain – a hallmark of Alzheimer’s disease and what is suggested as a cause of memory and cognition impairment.
Overseeing regulatory submissions for Leqembi, Eisai was initially supposed to file the rolling BLA in March 2024, but the FDA requested more immunogenicity data, leading to a delay in filing. The company eventually initiated the rolling submission in May. Eisai and Biogen are also awaiting potential approval for monthly Leqembi IV maintenance dosing, with the FDA PDUFA action date set for this month.
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By GlobalDataIn November 2024, Eisai reduced the sales forecast of Leqembi after a lower-than-anticipated uptake. Primarily citing delays in revenue in the US market, the Japanese pharma slashed $90m off the expected $370m target for the second half of the 2024 fiscal year. Leqembi’s launch in the US has been slow due to a variety of factors including regular infusion logistics and diagnosis constraints.
Eisai estimated at the time of its sales call that 10,000 patients with Alzheimer’s disease are eligible for Leqembi, of which 4,000 have started treatment.
Eisai is busy diversifying dosing administrations of its drug after Eli Lilly joined the Alzheimer’s treatment space with Kisunla (donanemab). The FDA approved Kisunla in July 2024 and is indicated in the same target population as Leqembi.
Leqembi seems to be benefitting from the first-to-market advantage, with the drug forecast to generate $5.3bn for Eisai and Biogen by 2030 while Kinsula is estimated to bring in $1.8bn for Eli Lilly, according to GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
While Eisai currently casts an eye over regulatory activities for Leqembi, Biogen has been attempting to solidify its position in the neuroscience sector. Last week, the company offered to purchase outstanding shares in Sage Therapeutics for around $442m, as per a Securities and Exchange Commission (SEC) filing. Sage said in response to Biogen, who already have a 10.2% stake in the company, that the proposal was “unsolicited” and “nonbinding”.
