StockholmAnd January 30, 2023 /PRNewswire/ — BioArctic AB’s (General) (NASDAQ Stockholm: BIOA B) Partner Eisai today announced that an application for manufacturing and marketing approval for lecanemab (generic name, US brand name: LEQEMBI™) is in Japan It has been designated for priority review by the Japanese Ministry of Health, Labor, and Welfare (MHLW). Lecanemab is a protofibril anti-amyloid-β (Aβ)[1] Antibodies for the treatment of Alzheimer’s disease (AD). Priority review in Japan It is awarded to new drugs recognized as having high medical benefit for critical illnesses, and once allocated for priority review, the overall target review period is shortened.
in JapanEisai has submitted manufacturing and marketing approval for lecanemab to the Medicines and Medical Devices Agency (PMDA) in January 16, 2023. This app is based on the results of the Clarity AD and Phase 3 Phase 3 study 2 b A clinical study showing that licanimab treatment showed a reduction in clinical deterioration in early AD.
Lecanemab selectively binds to and removes soluble toxic Aβ aggregates (primary fibrils) that are thought to contribute to neurotoxicity in Alzheimer’s disease. As such, lecanemab may have the potential to influence the pathology of the disease and slow the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all major secondary endpoints with highly significant results. in November 2022The results of the Clarity AD study are presented In 2022 Clinical Trials for Alzheimer’s Disease (CTAD) Conference and simultaneous publication in The New England Journal of MedicineIt is a peer-reviewed medical journal.
In the United States, lecanemab was granted fast-track approval as a treatment for Alzheimer’s disease by the US Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted an additional biological authorization (sBLA) application to the FDA for approval under the traditional route. in EuropeEisai submitted a Marketing Authorization (MAA) application with the European Medicines Agency (EMA) on January 9, 2023which was accepted in January 26, 2023. in ChinaEisai began submitting data for the BLA to the National Medicinal Products Administration (NMPA) in December 2022.
Eisai serves as the lead for lecanemab development and regulatory submissions globally with both Eisai and Biogen involved in the commercialization and co-promotion of the product and Eisai having the final decision-making power. BioArctic has the right to commercialize lecanemab in the North under certain conditions and is currently preparing for commercialization in the Nordic countries with Eisai. BioArctic bears no costs for developing lecanemab in Alzheimer’s disease and is entitled to payment in connection with regulatory filings, approvals and sales milestones as well as royalties on worldwide sales.
–
This information is information that BioArctic AB (public) is obligated to disclose under the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the responsible person below, on January 30, 2023in 00.30 am CET.
For more information, please contact:
Oscar Bussonand VP Communications and IR
Email: oskar.bosson@bioarctic.se
Tel: +46 70410 71 80
About priority review in Japan
Priority review is given to drugs that meet all of the following requirements. In addition, priority for review will be given to drugs classified as orphan drugs and lead drugs.
I. The qualifying disease is considered serious; And
Second. It is recognized that the efficacy or safety of a product is clearly superior to existing drugs, medical devices, regenerative medical products, or treatment modalities from a medical point of view.
About lecanemab
Lecanemab (US brand name: LEQEMBI™) is the result of a strategic research alliance between BioArctic and Eisai. Lecanemab is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ). Lecanemab selectively binds to and removes primary Aβ fibrils that are thought to contribute to neurotoxicity in Alzheimer’s disease. As such, lecanemab may have the potential to influence the pathology of the disease and slow the progression of the disease. In the United States, LEQEMBI has been granted accelerated approval by the US Food and Drug Administration (FDA). January 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer’s disease in the United States.Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or the moderate dementia stage of the disease, since treatment has begun in clinical trials. There are no safety or efficacy data when starting treatment at an earlier or later stage of the disease than has been studied. This indication was approved under accelerated approval based on the reduction of Aβ plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be conditional on verification of clinical benefit in a confirmatory trial. The Clarity AD study of lecanemab met its primary endpoint and all major secondary endpoints with highly significant results. Please see LEQEMBI US Description of information.
Eisai completed the subcutaneous bioavailability study of lecanemab and subcutaneous dosing is currently being evaluated in the Clarity AD open-label extension study.
where July 2020 The Eisai Phase III clinical study (AHEAD 3-45) of individuals with Alzheimer’s disease is still preclinical, meaning they are clinically normal and have moderate or elevated levels of amyloid in their brains. AHEAD 3-45 is being conducted as a public-private partnership between the Alzheimer’s Clinical Trials Consortium that provides the infrastructure for academic clinical trials in Alzheimer’s disease and related dementia in the United States, funded by the National Institute on Aging, part of the National Institutes of Health and ESAI.
where January 2022A clinical study of Tau NexGen for inherited AD (DIAD) is ongoing, with lecanemab being given as a primary anti-amyloid therapy when combination therapies with anti-tau therapies are explored. The study was conducted by the Dominantly Inherited Alzheimer’s Network Experiments Unit (DIAN-TU), led by Washington University Faculty of Medicine in Saint Louis.
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term cooperation with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most important of the agreements is the lecanemab antibody development and commercialization agreement, which was signed December 2007and the agreement for the development and commercialization of the BAN2401 stand-by antibody for Alzheimer’s disease, which was signed in May 2015. in March 2014Eisai and Biogen have entered into a joint development and marketing agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and marketing of Alzheimer’s products. BioArctic has the right to commercialize lecanemab in the North under certain conditions and is currently preparing for commercialization in the Nordic countries with Eisai. BioArctic bears no costs for developing lecanemab in Alzheimer’s disease and is entitled to payment in connection with regulatory filings, approvals and sales milestones as well as royalties on worldwide sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharmaceutical company focused on disease-modifying therapies for neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. BioArctic focuses on innovative therapies in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala UniversityAnd Sweden. Collaboration with universities is of great importance to the company along with its strategically important global partner Eisai in Alzheimer’s disease. The project portfolio is a mix of fully funded projects run in partnership with global pharmaceutical companies, innovative internal projects with significant market potential and external licensing. BioArctic’s Class B share is listed on the Nasdaq Stockholm Large Cap (stock ticker: BIOA B). For more information about BioArctic, please visit www.bioarctic.com.
[1] Primary fibrils are large soluble Aβ species of 75–500 kDa
The following files are available for download:
View original content:https://www.prnewswire.com/news-releases/bioarctic-lecanemab-receives-priority-review-status-in-japan-301733121.html
Source: BioArctic