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Arcturus Therapeutics and CSL Report EMA’s Validation of MAA for ARCT-154 Vaccine to Prevent COVID-19

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Arcturus Therapeutics

Arcturus Therapeutics and CSL Report EMA’s Validation of MAA for ARCT-154 Vaccine to Prevent COVID-19

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  • The EMA has validated the MAA for ARCT-154, a next-generation mRNA vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged ≥18yrs. The EC is expected an approval decision in 2024
  • The submission was based on the P-III clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster. The primary efficacy EP was met and ARCT-154 as a primary series resulted in 56.6% & 95.3% efficacy for prevention of symptomatic COVID-19 & sev. COVID-19 incl. COVID-19 related deaths
  • The additional P-III booster study showed non-inferiority of immune response over Comirnaty & superiority of ARCT-154 in neutralizing Ab response against SARS-CoV-2 Omicron BA.4/5 variant

Ref: Businesswire Image: Arcturus Therapeutics

Related News:- Gilead Receives the US FDA’s Approval of Veklury (remdesivir) sNDA for the Treatment of COVID-19 in Patients with Severe Renal Impairment

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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