www.fdanews.com/articles/203806-celltrion-gets-priority-review-in-canada-for-covid-19-antibody
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Celltrion Gets Priority Review in Canada for COVID-19 Antibody
August 3, 2021
Health Canada has granted Celltrion Healthcare a priority review for its investigational monoclonal antibody, regdanvimab (CT-P59), for the treatment of COVID-19.
Toronto, Ontario-based Celltrion filed its initial submission to the agency in late May for a rolling review, a process that allows the company to submit safety and efficacy data as the information becomes available.
Results from phase 1, 2 and 3 studies showed a promising safety, tolerability and efficacy in patients with mild-to-moderate COVID-19 symptoms, the company said, adding that regdanvimab demonstrated potency against the Delta variant of the SARS-COV-2 virus.