European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine
CSL (CSLLY) and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. The approval follows a positive CHMP opinion from December 12, 2024, and is valid across all EU member states and EEA countries.
KOSTAIVE, already marketed in Japan, demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on positive data from multiple studies, including an integrated phase 1/2/3 study and Phase 3 booster trials, which showed higher immunogenicity results versus a conventional mRNA COVID-19 vaccine comparator.
CSL (CSLLY) e Arcturus Therapeutics hanno annunciato che la Commissione Europea ha concesso l'autorizzazione alla commercializzazione per KOSTAIVE®, il primo vaccino COVID-19 a mRNA auto-amplificante, destinato a persone di 18 anni e oltre. L'approvazione segue un parere positivo del CHMP del 12 dicembre 2024 ed è valida in tutti gli stati membri dell'UE e nei paesi SEE.
KOSTAIVE, già commercializzato in Giappone, ha dimostrato un'immunogenicità superiore e persistenza degli anticorpi fino a 12 mesi dopo la vaccinazione rispetto ai vaccini COVID-19 a mRNA convenzionali in studi clinici. L'approvazione si basa su dati positivi provenienti da più studi, incluso uno studio integrato di fase 1/2/3 e prove di richiamo di fase 3, che hanno mostrato risultati di immunogenicità superiori rispetto a un vaccino COVID-19 a mRNA convenzionale di confronto.
CSL (CSLLY) y Arcturus Therapeutics anunciaron que la Comisión Europea ha otorgado la autorización de comercialización para KOSTAIVE®, la primera vacuna COVID-19 de ARNm autoamplificante, para personas de 18 años o más. La aprobación sigue a una opinión positiva del CHMP del 12 de diciembre de 2024 y es válida en todos los estados miembros de la UE y países del EEE.
KOSTAIVE, ya comercializado en Japón, demostró una inmunogenicidad superior y persistencia de anticuerpos de hasta 12 meses después de la vacunación en comparación con las vacunas COVID-19 de ARNm convencionales en ensayos clínicos. La aprobación se basa en datos positivos de múltiples estudios, incluido un estudio integrado de fase 1/2/3 y ensayos de refuerzo de fase 3, que mostraron resultados de inmunogenicidad más altos en comparación con un vacuna COVID-19 de ARNm convencional.
CSL (CSLLY)과 Arcturus Therapeutics는 유럽연합 집행위원회가 18세 이상의 개인을 위한 첫 번째 자가 증폭 mRNA COVID-19 백신인 KOSTAIVE®의 판매 승인을 부여했다고 발표했습니다. 이 승인은 2024년 12월 12일 CHMP의 긍정적인 의견에 따른 것이며, 모든 EU 회원국 및 EEA 국가에서 유효합니다.
일본에서 이미 판매 중인 KOSTAIVE는 임상 시험에서 기존 mRNA COVID-19 백신에 비해 백신 접종 후 최대 12개월까지 우수한 면역원성과 항체 지속성을 입증했습니다. 승인은 통합 1/2/3단계 연구 및 3단계 부스터 시험을 포함한 여러 연구의 긍정적인 데이터를 기반으로 하며, 기존 mRNA COVID-19 백신 비교군에 비해 더 높은 면역원성 결과를 보여주었습니다.
CSL (CSLLY) et Arcturus Therapeutics ont annoncé que la Commission Européenne a accordé une autorisation de mise sur le marché pour KOSTAIVE®, le premier vaccin COVID-19 à ARNm auto-amplifiant, pour les personnes de 18 ans et plus. L'approbation fait suite à un avis positif du CHMP du 12 décembre 2024 et est valable dans tous les États membres de l'UE et les pays de l'EEE.
KOSTAIVE, déjà commercialisé au Japon, a montré une immunogénicité supérieure et une persistance des anticorps pouvant aller jusqu'à 12 mois après la vaccination par rapport aux vaccins COVID-19 à ARNm conventionnels lors des essais cliniques. L'approbation repose sur des données positives provenant de plusieurs études, y compris une étude intégrée de phase 1/2/3 et des essais de rappel de phase 3, qui ont montré des résultats d'immunogénicité plus élevés par rapport à un vaccin COVID-19 à ARNm conventionnel.
CSL (CSLLY) und Arcturus Therapeutics haben bekannt gegeben, dass die Europäische Kommission die Marktzulassung für KOSTAIVE®, den ersten selbstverstärkenden mRNA COVID-19-Impfstoff, für Personen ab 18 Jahren erteilt hat. Die Genehmigung folgt einer positiven CHMP-Stellungnahme vom 12. Dezember 2024 und gilt in allen EU-Mitgliedstaaten sowie EEA-Ländern.
KOSTAIVE, das bereits in Japan vermarktet wird, zeigte in klinischen Studien eine überlegene Immunogenität und Antikörperpersistenz von bis zu 12 Monaten nach der Impfung im Vergleich zu herkömmlichen mRNA COVID-19-Impfstoffen. Die Genehmigung basiert auf positiven Daten aus mehreren Studien, einschließlich einer integrierten Phase 1/2/3-Studie und Phase 3 Auffrischungsstudien, die höhere Immunogenitätsergebnisse im Vergleich zu einem herkömmlichen mRNA COVID-19-Impfstoff zeigten.
- First sa-mRNA COVID-19 vaccine approved by European Commission
- Superior immunogenicity and antibody persistence for up to 12 months compared to conventional vaccines
- Marketing authorization valid across all EU member states and EEA countries
- Already commercially available in Japan market
- Technical enhancements still needed before European market launch
- Timeline for European market availability not specified
Insights
The European Commission's approval of KOSTAIVE marks a pivotal moment in vaccine technology advancement, positioning CSL and Arcturus at the forefront of next-generation vaccine development. The self-amplifying mRNA platform represents a significant technological leap, offering superior immunogenicity and unprecedented 12-month antibody persistence - a important differentiator in the competitive vaccine market.
The EU approval grants access to a market of over 448 million people across 27 member states, plus additional EEA countries. This extensive market reach, combined with KOSTAIVE's existing presence in Japan, establishes a robust commercial foundation. The sa-mRNA technology's demonstrated advantages over conventional mRNA vaccines position CSL to potentially capture significant market share, particularly in the booster segment where longer-lasting protection is highly valued.
Beyond immediate COVID-19 applications, this approval validates the sa-mRNA platform's potential, opening doors for its application across CSL's broader vaccine pipeline. The technology's ability to achieve higher immunogenicity with potentially lower doses could translate to improved cost-effectiveness and manufacturing efficiency, critical factors for long-term commercial success.
The strategic partnership between CSL and Arcturus combines CSL's global manufacturing and distribution capabilities with Arcturus's innovative sa-mRNA technology, creating a powerful competitive advantage. This collaboration could accelerate the development of next-generation vaccines for other infectious diseases, potentially establishing new revenue streams beyond the COVID-19 market.
- KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials
The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. The centralized marketing authorization of KOSTAIVE is valid in all EU member states and in the EEA countries.
"The European Commission's approval marks a significant milestone in our ongoing development program for KOSTAIVE," said Jonathan Edelman, MD, Senior Vice President of the Vaccines Innovation Unit, CSL. "We are actively working to optimize KOSTAIVE's formulation to better meet the needs of healthcare professionals and their patients. As COVID-19 remains an unpredictable global threat, CSL is dedicated to completing these technical enhancements and making this innovative vaccine available in
The approval is based on positive clinical data from several studies, including an integrated phase 1/2/3 study demonstrating KOSTAIVE's efficacy and tolerability, and Phase 3 COVID-19 booster trials, which achieved higher immunogenicity results compared to a conventional mRNA COVID-19 vaccine comparator. A follow-up analysis evaluating a booster dose of KOSTAIVE also showed that the vaccine elicited superior immunogenicity and antibody persistence for up to 12 months post-vaccination against multiple SARS-CoV-2 strains in both younger and older adult age groups versus the same mRNA comparator.
"KOSTAIVE and sa-mRNA technology signify a major advancement in vaccine innovation, providing the potential for broader and more enduring protection," said Joseph Payne, CEO of Arcturus. "This approval highlights the clinical promise of KOSTAIVE and its ability to protect against the ever-changing COVID-19 virus."
About sa-mRNA
mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.
About CSL
CSL (ASX: CSL; USOTC: CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.
For more information about CSL, visit www.CSL.com.
About Arcturus
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus' pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus' versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood of success (including safety, efficacy and commercialization) of KOSTAIVE, the likelihood that clinical results received to date will be predictive of future clinical results of protection against changing virus variants, the likelihood of optimizing KOSTAIVE's formulation and completing technical enhancements, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus' most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC's website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
CSL Media Contacts:
Sue Thorn, CSL
Mobile : +1 617-799-3151
Email: Sue.Thorn@cslbehring.com
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Email: Emmanuella.Dekonor@seqirus.com
In Australia:
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Mobile: +61 450 909 211
Email: Jimmy.Baker@csl.com.au
Investor Inquiries:
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Email: Chris.Cooper@csl.com.au
Arcturus Media Contact:
Public Relations & Investor Relations
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(858) 900-2682
IR@ArcturusRx.com
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