Celltrion’s CT-P59 (regdanvimab) Receives CHMP’s Positive Opinion for the Treatment of COVID-19

November 12, 2021 Auto Bot Celltrion, CHMP, CT-P59, regulatory 0

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

Click here to­ read the full press release/ article | Ref: Businesswire | Image: The Korea Economic Daily

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