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AstraZeneca announced Monday that the European Union drug regulator had accepted its market authorization application for accelerated assessment for sipavibart, an investigational COVID-19 prevention drug.
The submission was supported by positive data from a late-stage trial demonstrating sipavibart’s efficacy in reducing the risk of infection among patients with compromised immune systems.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) granted sipavibart accelerated assessment status, citing its significant potential for public health impact and therapeutic innovation.
AstraZeneca acquired sipavibart from RQ Bio in May 2022, underscoring its commitment to expanding its portfolio of COVID-19 treatments.
Earlier this year, AstraZeneca withdrew its COVID-19 vaccine from circulation, citing an oversupply of updated vaccines amidst the ongoing pandemic.
This move highlights AstraZeneca’s strategic focus on advancing new therapies like sipavibart to address evolving healthcare needs related to COVID-19.
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