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GSK Receives Authorization Under Health Canada's Interim Order for Sotrovimab for Injection to Treat Covid-19 in High-Risk Adults and Adolescents

07/30/2021 | 02:33pm
GSK announced that Health Canada has granted an Interim Order authorization for Sotrovimab for Injection (sotrovimab, previously VIR-7831) for the treatment of mild to moderate COVID-19, confirmed by direct SARS-COV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who are at high risk for progressing to hospitalization and/or death. The authorization of sotrovimab, a single-dose monoclonal antibody developed in collaboration with Vir Biotechnology, was granted under Health Canada'sInterim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Health Canada's Interim Order expedites authorization of medicines used for COVID-19, considering public health need. Health Canada's Interim Order authorization of sotrovimab is based on the interim analysis results from the pivotal Phase 3 trial, COMET-ICE.
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