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AstraZeneca: applies to EMA for Covid antibody
(CercleFinance.com) - AstraZeneca announces that the European Medicines Agency (EMA) has agreed to consider its marketing authorisation application for sipavibart under an accelerated assessment procedure.
Sipavibart is an investigational antibody for the prevention of COVID-19 in immunocompromised patients, who often do not respond adequately to vaccination.
The EMA's Committee for Medicinal Products for Human Use (CHMP) has granted this accelerated assessment in view of sipavibart's importance for public health and therapeutic innovation.
The application is based on the positive results of the Phase III SUPERNOVA trial, which demonstrated the safety and efficacy of sipavibart in the prevention of symptomatic COVID-19 in immunocompromised patients.
AstraZeneca is also collaborating with other regulatory authorities for the potential authorisation of sipavibart.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
Sipavibart is an investigational antibody for the prevention of COVID-19 in immunocompromised patients, who often do not respond adequately to vaccination.
The EMA's Committee for Medicinal Products for Human Use (CHMP) has granted this accelerated assessment in view of sipavibart's importance for public health and therapeutic innovation.
The application is based on the positive results of the Phase III SUPERNOVA trial, which demonstrated the safety and efficacy of sipavibart in the prevention of symptomatic COVID-19 in immunocompromised patients.
AstraZeneca is also collaborating with other regulatory authorities for the potential authorisation of sipavibart.
Copyright (c) 2024 CercleFinance.com. All rights reserved.