Celltrion’s Regdanvimab Receives the EC’s Approval for the Treatment of COVID-19

November 16, 2021 Auto Bot approval, Celltrion, EC, regulatory 0

Shots:

  • The EC has granted marketing authorisation for Celltrion’s regdanvimab in adults with COVID-19 who do not require supplemental oxygen & are at high risk of progressing to severe COVID-19
  • The approval is based on the P-III trial to evaluate the efficacy & safety of regdanvimab in 1315+ patients with COVID-19 across 13 countries including the US, Spain & Romania. The results showed a 72% reduction in risk of COVID-19 related hospitalization or death in high-risk patients
  • The company is currently discussing with the US FDA regarding submission of an application for a EUA & has reported the development of a neutralizing Ab cocktail with CT-P59 against new emerging variants of SARS-CoV-2

Click here to­ read the full press release/ article | Ref: Celltrion | Image: HT

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