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