Eisai will request reconsideration of initial decision for lecanemab in Australia

Rhea-AI Summary

BioArctic AB's partner Eisai announced that Australia's Therapeutic Goods Administration (TGA) initially decided not to register lecanemab, an antibody for treating mild cognitive impairment and mild dementia due to Alzheimer's disease. Eisai plans to request reconsideration within 90 days, with TGA's final decision expected 60 days after. Lecanemab, developed through BioArctic and Eisai's collaboration, is already approved in several countries including the US, Japan, and China.

The antibody originated from BioArctic's research based on Professor Lars Lannfelt's work. Eisai leads global development and regulatory submissions, with Eisai and Biogen co-commercializing the product. BioArctic retains commercialization rights in the Nordic region and is preparing for joint commercialization with Eisai in Europe, pending approval.

Positive

• Lecanemab is already approved in multiple major markets including the US, Japan, and China
• Eisai will request reconsideration of the initial decision in Australia, potentially leading to approval
• BioArctic has commercialization rights for lecanemab in the Nordic region

Negative

• Initial decision by Australian TGA not to register lecanemab for Alzheimer's treatment
• Delay in potential market entry for lecanemab in Australia

Insights

Pharmaceutical Industry Analyst

The TGA's initial decision not to register lecanemab in Australia is a setback for Eisai and BioArctic, but not entirely unexpected given the scrutiny Alzheimer's treatments face. Eisai's plan to request reconsideration keeps the door open for potential approval. The drug's existing approvals in major markets like the U.S., Japan and China are significant positives. For BioArctic, this news has immediate financial impact, as their primary markets are the Nordics and potentially Europe. However, a positive outcome in Australia could bolster confidence in lecanemab's global potential. Investors should monitor the reconsideration process closely, as it may influence perceptions of the drug's regulatory prospects in other markets, particularly Europe. The 90-day window for reconsideration and subsequent 60-day review period provide a clear timeline for potential catalysts.

Neuroscience Research Expert

Lecanemab's mechanism of targeting soluble aggregated amyloid-beta represents a promising approach in Alzheimer's treatment. Its approvals in multiple countries suggest a growing acceptance of this therapeutic strategy. The TGA's initial rejection raises questions about their specific concerns, which weren't detailed in the release. This could relate to efficacy data, safety profile, or cost-effectiveness considerations. The reconsideration process offers an opportunity for Eisai to address these concerns directly. For the scientific community, this regulatory back-and-forth underscores the ongoing debate about the amyloid hypothesis in Alzheimer's disease. The outcome in Australia could influence research directions and investment in similar approaches globally. It's important to note that lecanemab's success in other markets doesn't guarantee approval elsewhere, highlighting the complexities of Alzheimer's drug development and regulation.

STOCKHOLM, Oct. 16, 2024 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia.

Eisai will request a reconsideration of this initial decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia. Following Eisai's request for review, the TGA will issue a final decision within 60 days of receiving Eisai's request.

Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, Israel UAE and Great Britain, and is being marketed in the United States, Japan and China.

Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. 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 and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.

The information was released for public disclosure, through the agency of the contact persons below, on October 17, 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 

About lecanemab (Leqembi^®)

Lecanemab 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., Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab's approvals in these countries were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

Lecanemab marketed in the U.S., Japan and China. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union.

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 U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

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 innovative 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. 

 

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Eisai will request reconsideration of initial decision for lecanemab in Australia

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SOURCE BioArctic

FAQ

What was the initial decision by Australia's TGA regarding lecanemab (BIOA)?

The Therapeutic Goods Administration (TGA) of Australia initially decided not to register lecanemab for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD dementia.

How is Eisai responding to the TGA's initial decision on lecanemab (BIOA)?

Eisai will request a reconsideration of the initial decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early Alzheimer's disease in Australia.

In which countries is lecanemab (BIOA) currently approved?

Lecanemab is approved in the United States, Japan, China, South Korea, Hong Kong, Israel, UAE, and Great Britain, and is being marketed in the United States, Japan, and China.

What are BioArctic's (BIOA) commercialization rights for lecanemab?

BioArctic has the right to commercialize lecanemab in the Nordic region and is preparing for joint commercialization with Eisai in Europe, pending European approval.