Pharma Focus Europe

Arcturus Therapeutics and CSL's ARCT-154 COVID-19 Vaccine Application for Marketing Authorization Receives Validation From European Medicines Agency

Wednesday, September 06, 2023

Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global biopharmaceutical company specializing in the development of messenger RNA (mRNA) medicines. CSL (ASX: CSL), a leading provider of influenza vaccines, operates through its vaccine business, CSL Seqirus. These two entities jointly announced a significant milestone in their collaboration. The European Medicines Agency (EMA) has officially validated their marketing authorization application (MAA) for ARCT-154, an advanced mRNA vaccine designed to actively immunize individuals aged 18 and above against COVID-19, caused by the SARS-CoV-2 virus. An approval decision by the European Commission is anticipated in 2024.

The submission to the EMA is based on the promising results of a Phase 3 clinical trial of ARCT-154. This trial included both initial vaccination and booster shots against the original D614G variant of the virus. Data analysis over a 6-month period during the pivotal Phase 3 trial revealed that ARCT-154 met its primary efficacy endpoint, with an overall efficacy rate of 56.6% in preventing symptomatic COVID-19. Importantly, it demonstrated an impressive efficacy rate of 95.3% in preventing severe cases, including COVID-19-related deaths. It is noteworthy that this study took place during a period when the Delta variant was prevalent in Vietnam.

Additionally, data from the booster vaccine study, previously disclosed by CSL Seqirus' partner Meiji Seika Pharma, showed that ARCT-154 met its primary endpoint. It demonstrated non-inferiority in immune response compared to the Comirnaty® vaccine, which targets the original SARS-CoV-2 strain. Furthermore, ARCT-154 exhibited superiority in producing neutralizing antibodies against the SARS-CoV-2 Omicron BA.4/5 variant, a crucial secondary endpoint.

Joseph Payne, President & CEO of Arcturus Therapeutics, expressed their satisfaction with the EMA's acceptance of the marketing application for ARCT-154. He emphasized the significance of this milestone for advancing their innovative mRNA vaccine platform. Payne also highlighted the vaccine's adaptability to new variants of concern and its potential to provide longer-lasting protection against the ever-evolving COVID virus.

Emmanuelle Lecomte Brisset, Head of Global Regulatory Affairs at CSL, noted that this regulatory milestone brings CSL one step closer to introducing innovative mRNA vaccines in Europe. She expressed their commitment to collaborating with regulatory authorities to enhance public health protection.

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