Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency JCN Newswire

Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency

January 27, 2023
TOKYO and CAMBRIDGE, Mass., Jan 27, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab, an investigational anti-amyloid beta (Abeta) 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, for review following a standard timeline. In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway based on the results from the Phase III Clarity AD confirmatory study. In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022. 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 75-500 Kd.(1),(2)(1) "Lecanemab Sweeps up Toxic AΒ Protofibrils, Catches Eyes of Trialists." ALZFORUM, ALZFORUM, 21 Nov. 2021, bit.ly/3HzXXyE.(2) Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2): e32014. doi: 10.1371/journal.pone.0032014. Epub 2012 Feb 15. PMID: 22355408; PMCID: PMC3280222.For more information, visit www.eisai.com/news/2023/news202311.html. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)
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Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan JCN Newswire

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

January 16, 2023
TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).This application 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. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab. In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB(2): Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points. All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL(3). 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.In November 2022, the results of Clarity AD study were presented at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal the New England Journal of Medicine(New Window).In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. In China, Eisai initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022.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.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2023/news202307.html.MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman+ 1-201-753-1945Libby_Holman@eisai.com INVESTOR CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL: +81-(0)03-3817-5122 Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)
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Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe JCN Newswire

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

January 11, 2023
TOKYO, Jan 11, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to a validation to determine whether the EMA accepts the application for review.The Clarity AD study met its primary endpoint (CDR-SB(1): Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly 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.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, peer-reviewed medical journals.In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In China, Eisai has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai's fiscal year 2022, which ends March 31, 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.(1) CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.Media Contacts:Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Europe, Ltd.(Europe, Australia, New Zealand and Russia)EMEA Communications Department+44 (0) 786 601 1272EMEA-comms@eisai.netBiogen Inc.Natacha Gassenbach+ 1-857-777-6573public.affairs@biogen.comInvestor Contacts: Eisai Co., Ltd. Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Mike Hencke+ 1-781-464-2442IR@biogen.com Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)
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Audiolox Announces Early-Stage Fundraising Pledge by Investors Surpassed Its Seed Round Target by 20% SeaPRwire

Audiolox Announces Early-Stage Fundraising Pledge by Investors Surpassed Its Seed Round Target by 20%

October 6, 2022
NEW YORK, NY,October 06, 2022- (SEAPRWire) – Audiolox, a blockchain-powered and secure music platform, announced that the early-stage pledges from investors were 20% higher than its seed round target. The Dubai-based company was launched on October 5, 2022, and is already attracting investors’ confidence. The event, held at the Dubai SLS hotel’s convention hall, was anchored by CLS. The idea for the creation of Audiolox was first conceptuliazed in 2019, as a blockchain streaming application. However, after seeing the challenges artists face with contracts from record labales and notable streaming giants, incesant breach of users’ data, etc. the team decided to combine blockchain technology and artificial intelligence. This innovative approach gave birth to the Audiolox Secure Music Platform. According to the founding team, the mission of the project is to be the first platform that allows writers, singers, producers, etc to share music with a large audience in a fast, secure, and environmentally safe manner. One of the major highlights of the project launch was the presentation of the Audiolox technology to the guests by Dr. Mark Lane, the brain behind the creation of Audiolox music application. After the presentation, there was an exclusive private rooftop after-party where VIPs could interact with crypto leaders and experts. In his statement, Dr. Mark revealed that “Audiolox is the first fully decentralized Web3 Secure Music Application based on the new Loxsync Technologies Artificial Intelligence structure.” Dr. Mark Lane is the founder and Chief Technical Officer (CTO) of Audiolox technologies. He is also the Project contractor for a number of well-known companies. The Project Roadmap Below are the development plans for the Audiolox project: Q3 2022: Assembling computational and forecasting evaluation structures.Q4 2022: commencing ICO filing, launching the Alpha version, and auditing the community development’s platformQ1 2023: Make improvements to the platform’s users’ feedback. Establish R&D Department. Platform expansion. DEX % CEX Listings.Q2 2023: commencing the app’s Beta version, attaining the 1 million users’ milestone, and presenting the platform’s development analysis report.Q3 2023: advancing associated AI platforms like Healthlox, Sportslox, Cinemalox, Crimelox, Casinolox, and other banking apps. About Audiolox Audiolox is a Web3 decentralized music application. Motivated by the difficulties encountered with web2 music applications, such as the use of third-party databases for storing files which makes it vulnerable for hackers to infiltrate, and the low-income base for the various music platforms, the founding team created Audiolox to reposition the music industry towards the future by utilizing web3 features and blockchain structures. Audiolox is an innovative and revolutionary new Artificial Intelligence music app technology, mainly developed to serve the music industry. The infrastructures of Audiolox were developed from the mix of blockchain and Loxsync’s AI features, the first of its kind. Driven by the desire to craft a difference in the music industry, the Audiolox team came up with the first-ever blockchain and web3-inspired music application specifically designed to serve the needs of songwriters, producers, users, and artists. Audiolox is gradually adopting full decentralization status within the music industry. This is possible given the presence of blockchain infrastructures and the new AI. Moreover, Audiolox offers a competitive payout package to its users. Users earn One Penny Per Play (OPPP), the highest for any existing music application. ALOX is a dual-purpose token that will be used within the Audiolox application. First, the token will help the team to raise the last round of funding required to complete the full development of the Audiolox application. The second use case of the ALOX token is that it will serve as a utility token for in-app transactions like individual subscriptions and online merchandise. Social Media Twitter: https://twitter.com/aloxtoken Telegram: https://t.me/aloxtoken Facebook: https://www.facebook.com/aloxtoken Instagram: https://www.instagram.com/aloxtoken.official/ LinkedIn: https://www.linkedin.com/in/alox-utility-token-4097a3246/ Reddit: https://www.reddit.com/r/Aloxtoken/ Tiktok: https://www.tiktok.com/@aloxtoken?is_from_webapp=1&sender_device=pc Media Contact Company Name: Audiolox Secure Music Application Contact Person: Dr. Mark Lane Contact Person Title: CTO Company Website: www.aloxtoken.com Company Email: info@aloxtoken.com Source:Audiolox Secure Music Application The article is provided by a third-party content provider. SEAPRWire ( https://www.seaprwire.com/ ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Hong Kong: AsiaExcite, EastMud; AsiaEase; Singapore: SEAChronicle, VOASG; NetDace; Thailand: SEAsiabiz, AccessTH; Indonesia: SEATribune, DailyBerita; Philippines: SEATickers, PHNotes; Malaysia: SEANewswire, KULPR; Vietnam: SEANewsDesk, PostVN)
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