FDA accepts filing of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's Disease
The FDA has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly intravenous (IV) maintenance dosing of Leqembi® (lecanemab-irmb) for early Alzheimer's Disease (AD). A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. Leqembi is designed to treat patients with mild cognitive impairment or mild dementia. The sBLA is based on data from the Phase 2 Study 201, its open-label extension (OLE), and the Clarity AD study. If approved, the monthly dosing regimen would be less burdensome, aiding long-term treatments. Eisai has also initiated a rolling submission to the FDA for a Leqembi subcutaneous autoinjector for weekly dosing. Leqembi is currently approved in several countries, and BioArctic is entitled to payments and royalties from its sales, with rights to commercialize in the Nordic region pending European approval.
- FDA acceptance of Eisai's sBLA for Leqembi's less frequent dosing.
- Set PDUFA action date for January 25, 2025.
- Leqembi's potential approval for less burdensome monthly IV dosing.
- Data from Studies 201, 301, and their OLEs support prolonged benefits.
- Initiated rolling submission for Leqembi subcutaneous autoinjector with Fast Track designation.
- Leqembi approved in major markets including the U.S., Japan, China, and South Korea.
- BioArctic entitled to payments on regulatory approvals, sales milestones, and global sales royalties.
- BioArctic has commercialization rights in the Nordic region, pending European approval.
- No specific timeline for the duration of the biweekly IV initiation phase provided.
- Pending regulatory approval, the timeline for market availability remains uncertain.
- BioArctic's financial benefit hinges on successful regulatory approvals and market uptake.
Insights
The FDA's acceptance of Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly dosing of Leqembi is a significant development. Alzheimer's Disease (AD) is a progressive ailment and finding effective treatments is a high priority in medical research. The approval for a less frequent dosing regimen could make treatment more accessible and less burdensome for patients, potentially improving compliance and outcomes.
The data supporting the sBLA, derived from Phase 2 and Phase 3 studies, indicate that the monthly dosing can maintain effective drug concentrations. This sustained clearance of amyloid beta protofibrils is important because these toxic proteins are implicated in the progression of AD. Additionally, the initiation of a rolling submission for a subcutaneous autoinjector signifies further commitment to patient-centric treatment options, which can be pivotal for long-term management of AD.
Despite these positive signals, investors should remain cautious until more detailed data is available. The efficacy and safety of the less frequent dosing will be closely scrutinized by the FDA and any unexpected findings could impact the final approval.
From a financial perspective, the acceptance of the sBLA is a positive catalyst for both BioArctic AB and its partner Eisai. If approved, the less frequent monthly dosing regimen could lead to increased market penetration and higher patient adherence, both of which could drive revenue growth. This is particularly pertinent given the extensive geographic scope of Leqembi's current approvals and pending applications, which include major markets like the US, Japan and the EU.
BioArctic's financial exposure is minimized due to Eisai bearing the development costs and BioArctic benefiting from milestone payments and royalties. Therefore, the approval of the sBLA could bolster BioArctic's financial stability and provide a steady stream of income through royalties. However, investors should keep an eye on regulatory outcomes in other jurisdictions to fully understand the global revenue potential.
As part of the monthly IV maintenance regimen, the patients who have completed the biweekly IV initiation phase, exact period under discussion with the FDA, would receive a less frequent monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic amyloid beta (Aβ) protofibrils[i] which can continue to cause neuronal injury. The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its open-label extension (OLE) as well as the Clarity AD study (Study 301) and its OLE study.
Alzheimer's disease is a progressive disease caused by toxic amyloid proteins. Once established, this pathophysiological process continues through the patient's life and therefore sustained treatment is necessary. The treatment should be initiated as early as possible to maximize patient outcomes. Data from Studies 201, 301 and their OLEs show that continued treatment with LEQEMBI beyond the 18-month core phase prolongs the benefit as highly toxic protofibrils are continuously removed. If approved, the clinical and biomarker benefits may be maintained through the once-monthly dosing regimen that is less burdensome and easier for patients and care partners to continue long-term.
Additionally, Eisai initiated the rolling submission of a BLA to the FDA for the Leqembi subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA in May 2024.
Leqembi is now approved in the
Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer's disease. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalties on global sales. In addition, BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons below, on June 10, 2024, at 01.30 a.m. CET.
For further information, please contact:
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
Jiang Millington, Director Corporate Communication and Social Media
E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 166
About lecanemab (generic name,
Lecanemab (Leqembi) is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved in the
U.S. : For the treatment of Alzheimer's disease (AD). It should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. See full US prescribing information including boxed warning.Japan : For slowing progression of mild cognitive impairment (MCI) and mild dementia due to AD.China : For the treatment of MCI due to AD and mild AD dementia.South Korea : For treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD (early AD)
Lecanemab approvals were based on the large global Phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.
Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.
[i] Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition. Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.
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