Celltrion's CT-P59 (regdanvimab) Receives CHMP's Positive Opinion for the Treatment of COVID-19
Shots:
- The EMA's CHMP has issued a positive opinion recommending the marketing authorization for regdanvimab (CT-P59) in adults with COVID-19 who do not require supplemental oxygen & are at increased risk of progressing to severe COVID-19
- The CHMP opinion was based on the P-III clinical trial to evaluate the efficacy and safety of regdanvimab in 1315+ patients with COVID-19 across 13 countries including the US, Spain & Romania. The results showed a 72% reduction in the risk of COVID-19 related hospitalization or death in high-risk patients
- The company has recently reported the development of a neutralizing Ab cocktail in combination with CT-P59 against new emerging variants of SARS-CoV-2
Ref: Businesswire | Image:Celltrion
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