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

 Ref: Celltrion | Image: Celltrion