Lecanemab obtains Fast Track designation by the FDA

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STOCKHOLM, December 24, 2021 / PRNewswire / – BioArctic AB (published) (Nasdaq Stockholm: BIOA B) Partner Eisai today announced that lecanemab, an investigational anti-protofibril beta-amyloid (Aβ) antibody for the treatment of early-onset Alzheimer’s disease (AD), has received Fast Track designation from the Food and Drug Administration (FDA) of the United States. The FDA granted the Breakthrough Therapy designation for lecanemab in June 2021. The Breakthrough Therapy designation and the Fast Track designation are two FDA programs that aim to facilitate and accelerate the development of new drugs to meet unmet medical needs in the area. the treatment of a serious or life-threatening illness. disease such as AD and provide opportunities for frequent interactions with the FDA.

In September 2021, Eisai has initiated an ongoing submission to the FDA of a Biologics License Application (BLA) for lecanemab under the fast-track approval process. The BLA is mainly based on clinical, biomarker and safety data from the phase 2b clinical study in people with early-onset AD and confirmed amyloid disease. The non-clinical and clinical parts of the application which consists of three parts (non-clinical, clinical and CMC) have already been submitted. The lecanemab phase 2b study results demonstrated a high degree of Aβ plaque lowering and a consistent reduction in clinical decline across several clinical endpoints. The correlation between the extent of Aβ plaque reduction and the effect on clinical parameters of the phase 2b The study further supports Aβ as a surrogate endpoint that is reasonably likely to predict clinical benefit.

The phase 3 clinical study of lecanemab Clarity AD in early-onset Alzheimer’s disease is ongoing and has completed recruitment in March 2021 with 1795 patients. The FDA has accepted that Clarity AD can be used as a confirmatory study to verify the clinical benefit of lecanemab. Blinded security data from Clarity AD is included to support ongoing submission for expedited approval. Another phase 3 clinical study, AHEAD 3-45, evaluates the efficacy of treatment with lecanemab in cognitively normal participants with preclinical AD and elevated amyloid and in participants with preclinical early AD and intermediate amyloid. In addition, Eisai has initiated a Phase 1 study of the subcutaneous administration of lecanemab.

Alzheimer’s disease is a serious, progressive and devastating disease with few treatment options. BioArctic and Eisai are committed to bringing new treatment options to people living with early-onset AD, their families and the healthcare professionals waiting for them.

This press release discusses experimental uses of an agent under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that experimental uses of such a product will successfully complete clinical development or obtain approval from health authorities.

For more information, please contact:

Gunilla Osswald, CEO

Email: gunilla.osswald@bioarctic.se

Telephone: +46 8 695 69 30

Oskar Bosson, VP Communications and RI

Email: oskar.bosson@bioarctic.se

Telephone: +46 70 410 71 80

This information is information that BioArctic AB (publ) is obliged to disclose in accordance with the EU Market Abuse Regulation. The information has been made public, through the above contact persons, on December 24, 2021, at 1h35 CET.

Note to editors

About lecanemab (BAN2401)

Lecanemab is an experimental humanized monoclonal antibody for Alzheimer’s disease (AD) which is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab binds, neutralizes and selectively removes toxic soluble Aβ aggregates (protofibrils) believed to contribute to the neurodegenerative process of AD. As such, lecanemab has the potential to have an effect on disease pathology and slow disease progression. Eisai has obtained the worldwide rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in december 2007. In March 2014, Eisai and Biogen have entered into a joint development and commercialization agreement for lecanemab. Currently, lecanemab is being investigated in a pivotal phase 3 clinical study in early symptomatic AD (Clarity AD), following completion of phase 2b clinical study (Study 201). As of July 2020, the phase 3 clinical study, AHEAD 3-45, for people with preclinical (asymptomatic) AD, which means they are clinically normal and have intermediate or high levels of cerebral amyloid, has been launched. AHEAD 3-45 will evaluate the efficacy of lecanemab in pre-symptomatic people and is being conducted as part of a public-private partnership between the Alzheimer’s Clinical Trial Consortium, funded by the National Institute on Aging, the National Institutes of Health and Eisai. DIAN-TU selected lecanemab as a background anti-amyloid agent to be included in the Tau NexGen study in Alzheimer’s disease with dominant transmission. In June 2021, the FDA has granted breakthrough therapy designation to lecanemab and September 2021, Eisai has initiated an ongoing submission for the US FDA biologics license application for lecanemab for the treatment of early-onset Alzheimer’s disease under the fast-track approval process. Eisai expects the continuous submission to be completed in the first half of 2022.

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 Agreement for the development and commercialization of the lecanemab antibody, which was signed in december 2007, and the agreement for the development and commercialization of the backup antibody BAN2401 for Alzheimer’s disease, signed in May 2015. Eisai is responsible for clinical development, marketing authorization application and marketing of products for Alzheimer’s disease. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments as part of regulatory filings, approvals and sales milestones.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharmaceutical company specializing in disease-modifying therapies and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. BioArctic focuses on innovative treatments in areas where unmet medical needs are high. The company was founded in 2003 on the basis of innovative research by Uppsala University, Sweden. Collaborations with universities are of great importance for the company as well as its strategically important global partners in the Alzheimer (Eisai) and Parkinson (AbbVie) projects. The project portfolio is a combination of fully funded and partnered projects with global pharmaceutical companies and innovative in-house projects with significant market and licensing potential. BioArctic’s Class B share is listed on the Nasdaq Stockholm Mid Cap (ticker: BIOA B). For more information on BioArctic, please visit www.bioarctic.com.

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