Celltrion’s Regdanvimab (CT-P59) Receives Korean MFDS Conditional Marketing Authorization for COVID-19

 Celltrion’s Regdanvimab (CT-P59) Receives Korean MFDS Conditional Marketing Authorization for COVID-19

Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

Shots:

  • The CMA is based on P-II/III study assessing CT-P59 vs PBO in patients with COVID-19. The CMA allows the emergency use of CT-P59 in patients aged ≥ 60yrs. with medical condition & mild symptoms of COVID-19, and adult with mod. symptoms of COVID-19
  • The study showed a reduction in risk of COVID-19 related hospitalization & oxygenation @28days; reduction in progression rates (54% for mild-to-mod. patients & 68% for mod. patients aged ≥50yrs.); time to clinical recovery (3.4 to 6.4days)
  • Celltrion is in discussion with the EMA for CMA and with the US FDA for EUA. The global P-III clinical trial is on track and is expected to enroll 1,172 patients with mild-to-mod. symptoms of COVID-19

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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