Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease
TOKYO and CAMBRIDGE, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.
The NDS is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly 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.
Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase II data that demonstrated that lecanemab reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of lecanemab’s clinical benefit in a confirmatory trial. The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.
In the U.S., Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023. On March 3, 2023, the FDA accepted Eisai’s sBLA based on the Clarity AD clinical data, and the lecanemab application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application on June 9, 2023. In Japan, Eisai submitted an application for manufacturing and marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. Priority Review was granted by the Ministry of Health, Labour and Welfare (MHLW) on January 26, 2023. Eisai utilized the PMDA’s prior assessment consultation system, with the aim of shortening the review period for lecanemab. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023, which was accepted on January 26, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022, and Priority Review was granted on February 27, 2023.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
* Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.1
1 Söderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab - Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics (2022). https://doi.org/10.1007/s13311-022-01308-6. Accessed February 9, 2023
Eisai Co., Ltd.
Public Relations Department
Eisai Inc. (U.S.)
Eisai Co., Ltd.
Investor Relations Department
[Notes to editors]
1. About Lecanemab
Lecanemab (Brand Name in the U.S.: LEQEMBI™) is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). In the U.S., LEQEMBI was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in Aβ plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
Please see full Prescribing Informationin the United States.
Eisai has completed lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD OLE.
Since July 2020 the 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, Eisai and Biogen. 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, has been ongoing since January 2022.
2. About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
4. About Eisai Co., Ltd.
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.
5. About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Nokia Corporation: Repurchase of own shares on 26.09.202326.9.2023 20:00:00 CEST | Press release
Nokia Corporation Stock Exchange Release 26 September 2023 at 21:00 EEST Nokia Corporation: Repurchase of own shares on 26.09.2023 Espoo, Finland – On 26 September 2023 Nokia Corporation (LEI: 549300A0JPRWG1KI7U06) has acquired its own shares (ISIN FI0009000681) as follows: Trading venue (MIC Code)Number of sharesWeighted average price / share, EUR*XHEL311,0543.56CEUX55,9623.57AQEU8,7573.55TQEX16,2273.57Total392,0003.56 * Rounded to two decimals On 3 February 2022, Nokia announced that its Board of Directors is initiating a share buyback program under the authorization granted by Nokia’s Annual General Meeting on 8 April 2021 to return up to EUR 600 million of cash to shareholders in tranches over a period of two years. The second phase of the share buyback program in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR), the Commission Delegated Regulation (EU) 2016/1052 and under the authorization granted by Nokia’s Annual General Meeting on 5 April 2022 started on 2 Januar
Sunstone IV hf. announces Consolidated Condensed Interim Financial Statements for the six months ended June 30, 202326.9.2023 19:56:38 CEST | Press release
Sunstone IV hf. Storhofdi 22-30, 110 Reykjavik, Iceland Sunstone IV hf. announces Consolidated Condensed Interim Financial Statements for the six months ended June 30, 2023 Consolidated condensed interim financial statements, for the six months ended June 30, 2023 of Sunstone IV hf. were approved at a Board of Directors meeting on 21 September 2023. The financial statements can be found on the Company’s website: https://www.mila.is/um-milu/fjarmal/sunstone-iv/ For more information please contact: Inga Helga Halldórudóttir Compliance officer Sunstone IV hf. email@example.com
Nokia to bring semiconductor expertise to CHIPS and Science Act funded innovation hub26.9.2023 18:20:01 CEST | Press release
Press Release Nokia to bring semiconductor expertise to CHIPS and Science Act funded innovation hub Nokia will join a new innovation hub that seeks to expand U.S. global leadership in microelectronics technical development.The program will help reduce U.S. reliance on foreign microelectronics and safeguard supply chain risks, while ensuring access to cutting edge semiconductors for the Department of Defense. 26 September 2023 Murray Hill, New Jersey – Nokia today announced that it is part of the Northeast Microelectronics Coalition (NEMC) Hub, a regional innovation hub led by the Massachusetts Technology Collaborative (MassTech). The NEMC Hub was recently awarded funding to advance the microelectronics needs of the U.S. Department of Defense (DoD) from the "Creating Helpful Incentives to Produce Semiconductors (CHIPS) and Science Act." The funding award will establish a total of eight Microelectronics Commons regional innovation hubs and Core Facilities distributed across the United St
ABC arbitrage : Continuation of liquidity contract of ABC ARBITRAGE26.9.2023 18:00:00 CEST | Press release
Continuation of liquidity contract of ABC ARBITRAGE ABC ARBITRAGE informs that it will continue the liquidity contract with Kepler Cheuvreux, adding the following additional resources: 80,000 in cash (transfer executed on 21 September 2023). As a reminder : • the following resources appeared on the last half year statement on 30 June 2023 on the liquidity account: - 51,410 shares - € 111,829.43 - Number of executions on buy side on semester: 783 - Number of executions on sell side on semester: 1,120 - Traded volume on buy side on semester: 125,924 shares for € 781,516.85 - Traded volume on sell side on semester: 115,527 shares for € 719,846.14 • the following resources appeared on the liquidity account when the activity started: - 28,440 shares - € 49,007.93 The implementation of this report is carried out in accordance with AMF Decision N°2021-01 of June 22nd 2021 renewing the implementation of liquidity contracts for shares as an accepted market practice. Contacts : abc-arbitrage.com
ROBIT PLC: REPURCHASE OF OWN SHARES 26 SEPTEMBER 202326.9.2023 17:45:00 CEST | Press release
ROBIT PLC STOCK EXCHANGE RELEASE 26 SEPTEMBER 2023 AT 18.45 EEST ROBIT PLC: REPURCHASE OF OWN SHARES26 SEPTEMBER 2023 Robit PlcNasdaq Helsinki LtdDate26.9.2023Exchange transactionBUYShare trading codeROBITAmount, shares1765Average price / share, EUR1,453666Total cost, EUR2565,72 Robit Plc now holds a total of 17 479 shares including the shares repurchased on 26 September 2023. Detailed information concerning the repurchase is attached to this stock exchange release. On behalf of Robit Plc OP Corporate Bank Mikael Ahovuo Further information: Robit Plc Arto Halonen, Group CEO +358 40 028 0717 firstname.lastname@example.org Distribution: Nasdaq Helsinki Ltd Key media www.robitgroup.com Robit is the specialist focused on high quality drilling consumables for the mining and construction markets globally to help you drill even Further. Faster. Robit strives to be the world’s number one drilling consumables company. Through our proven, high-quality Top Hammer, Down the Hole and Geotechnical prod