Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for subcutaneous maintenance dosing
Eisai has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. FDA for Leqembi® (lecanemab-irmb) subcutaneous maintenance dosing. This follows the FDA granting Fast Track designation to Leqembi for Alzheimer's disease treatment in early AD stages. Currently approved for biweekly intravenous (IV) treatment, Leqembi's subcutaneous autoinjector simplifies home treatment, reducing the need for hospital visits. The BLA relies on Phase 3 Clarity AD open-label extension study data and aims to maintain effective drug concentrations to sustain clearance of toxic protofibrils. Leqembi is already approved in the US, Japan, and China, with additional applications under review globally. Eisai leads the global development and regulatory submissions, while BioArctic holds commercialization rights in the Nordic region pending European approval.
- Eisai initiated the rolling BLA submission for Leqembi subcutaneous dosing to the U.S. FDA.
- Leqembi received Fast Track designation from the FDA.
- Simplified home treatment with subcutaneous autoinjector reduces the need for hospital visits.
- Based on data from the Phase 3 Clarity AD open-label extension study.
- Leqembi is already approved in the U.S., Japan, and China.
- Applications for Leqembi are under review in multiple global regions.
- Eisai leads global development and regulatory submissions.
- BioArctic holds commercialization rights in the Nordic region, pending European approval.
- The BLA submission indicates ongoing dependency on regulatory approval processes.
- Subcutaneous dosing approval is still pending, potentially delaying market entry.
- Financial impact on BioArctic and Eisai remains uncertain pending FDA approval.
- The need for continued treatment implies long-term patient commitment and costs.
- Pending applications in other regions may face regulatory hurdles.
Insights
The initiation of the Biologics License Application (BLA) for Leqembi (lecanemab-irmb) subcutaneous autoinjector signifies a notable advancement in Alzheimer's treatment. The subcutaneous administration offers a potentially more convenient and less invasive alternative to the traditional intravenous (IV) treatment. This could be particularly beneficial for patients who have limited mobility or who find frequent hospital visits difficult.
From a medical perspective, simplifying the treatment process may lead to better adherence to the treatment regimen. Consistent treatment is critical in managing Alzheimer's, as it helps maintain effective drug concentrations necessary for the clearance of toxic amyloid-beta (Aβ) protofibrils.
Additionally, the Phase 3 Clarity AD open-label extension (OLE) study provides supportive data, although the broader clinical community will need to evaluate these findings further. If approved, this subcutaneous option could become a significant milestone in Alzheimer's care, offering a more patient-friendly approach while maintaining therapeutic effectiveness.
In summary, this development represents a potentially transformative option for Alzheimer's treatment, making it more accessible and manageable for patients and caregivers.
The rolling submission of the Biologics License Application (BLA) for Leqembi's subcutaneous administration is a substantial step for Eisai and its partners, including BioArctic. This move could significantly enhance the marketability of Leqembi by addressing the convenience factor for patients and caregivers. The potential shift from biweekly IV administration to a more manageable weekly subcutaneous injection could lead to increased patient adherence and, consequently, higher sales volumes.
Investors should note the broader market implications, as the approval of this new dosing method could expand the treatment's market penetration. Given that Eisai serves as the lead for global development and regulatory submission and with BioArctic having commercialization rights in the Nordic region, approvals in additional regions could further boost revenues.
Furthermore, the FDA's Fast Track designation emphasizes the urgency and potential impact of this treatment, which may expedite the review process. However, investors should remain cautious and consider the competitive landscape and ongoing costs associated with these regulatory and development processes.
Overall, this development could enhance the revenue streams and market positioning of both Eisai and BioArctic, assuming successful regulatory approval and market adoption.
For retail investors, it's important to understand the broader market dynamics at play. Alzheimer's disease treatments are a rapidly evolving segment with significant unmet needs. The introduction of a subcutaneous autoinjector for Leqembi could position the product favorably against competitors who are still relying on traditional IV methods. This convenience factor not only benefits patients but also aligns well with trends toward home-based healthcare solutions, which have seen increased interest post-pandemic.
Moreover, the existing approval in major markets like the U.S., Japan and China, along with pending applications in other significant regions, indicates a robust global strategy. The advantage of a simpler administration method could make Leqembi a preferable option for early-stage Alzheimer's patients globally, potentially capturing a larger market share.
Investors should keep an eye on how this product differentiates itself in the market and its acceptance by healthcare providers and patients. The success of the subcutaneous formulation could enhance brand loyalty and long-term revenue stability.
Leqembi is approved for biweekly intravenous (IV) treatment, which is normally done at medical facilities. Subcutaneous administration with an autoinjector simplifies home treatment and the injection process requires less time than the IV formulation. This makes the treatment easier for patients and their care partners and may reduce the need for hospital visits and nursing care compared to IV administration, in addition to being more convenient for patients to continue the treatment.
Alzheimer's disease is an ongoing neurotoxic process that begins before and continues after amyloid-beta (Aβ) plaque deposition, which is a hallmark of the disease. Data suggests that early and continued treatment may prolong the benefit even after Aβ plaque is cleared from the brain. If approved by the FDA, patients who have completed the biweekly IV initiation phase could transfer to the subcutaneous autoinjector 360 mg weekly maintenance regimen, currently under review. This would maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils[i] which can continue to cause neuronal injury even after the Aβ plaque has been cleared from the brain. The BLA is based on data from the Phase 3 Clarity AD open-label extension (OLE) study, and modeling of observed data.
Leqembi is now approved in the
Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. 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 May 15, 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 waring.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.
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.
Eisai has also submitted applications for approval of lecanemab in 14 countries and regions, including the European Union (EU).
Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE) study. A maintenance dosing regimen has been evaluated as part of the Phase 2b study (Study 201).
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.se.
[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.ii 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.iii
ii Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
iii Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
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