Dailypharm Live Search Close

Regkirona's indication expansion has been requested

By Lee, Tak-Sun | translator Choi HeeYoung

21.08.11 09:16:19

°¡³ª´Ù¶ó 0
permission change to the MFDS and treatment for patients aged 12 or older with mild or moderate symptoms



Celltrion's COVID-19 antibody therapy Regkirona is pushing for an expansion of indications based on global phase 3. Regkirona was conditionally approved to submit a clinical trial result report for therapeutic confirmation in February and was used only in patients with mild to secondary COVID groups. Celltrion submitted a report on the results of the clinical trial and applied for a change in efficacy from all mild cases over the age of 12 to secondary patients.

The MFDS announced on the 10th that Celltrion has applied for a change in permission of the COVID-19 antibody treatment drug Regkirona (Regdanvimab) based on a global phase 3. Changes include ¡ã deletion of permission conditions ¡ã expansion of

Lee, Tak-Sun(hooggasi2@dailypharm.com)
If you want to see the full article, please JOIN US (click)