Celltrion Gets Priority Review in Canada for COVID-19 Antibody

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.