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

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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

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

 ­ Ref: Businesswire | Image: Celltrion

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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