Press release
Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization Application for ARCT-154 Vaccine to Prevent COVID-19
EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met An additional Phase 3 booster study
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"\nEMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met\n\n\nAn additional Phase 3 booster study demonstrating non-inferiority of immune response compared to Comirnaty® and superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was shown as a key secondary endpoint\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nArcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, and CSL (ASX:CSL), and its vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, announced today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154, a next generation mRNA vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The companies (Arcturus and CSL Seqirus) anticipate an approval decision by the European Commission in 2024.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230905857902/en/\nThe EMA submission is based on successful Phase 3 clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster. In an analysis of 6-month data from the pivotal Phase 3 study, the primary efficacy endpoint was met and ARCT-154 as a primary series resulted in 56.6% efficacy for prevention of symptomatic COVID-19 overall, and 95.3% efficacy for prevention of severe COVID-19 including COVID-19 related deaths. The study was conducted when Delta variant was dominant in Vietnam. The booster data result was previously announced by CSL Seqirus’ partner, Meiji Seika Pharma, indicating that the primary endpoint was achieved in a Phase 3 booster vaccine study by demonstrating non-inferiority of immune response against SARS-CoV-2 ancestral strain compared to Comirnaty®. Superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was a key secondary endpoint.\n\n\n“EMA acceptance of the marketing application for ARCT-154 represents another major achievement in the development of this innovative mRNA v...