Celltrion Applies for Formal European Marketing Authorization of COVID-19 Treatment
[Asia Economy Reporter Park Jihwan] Celltrion announced on the 5th that it has officially submitted a marketing authorization application to the European Medicines Agency for its COVID-19 treatment (CT-P59).
The treatment target is adult patients aged 18 and older who have been confirmed positive for COVID-19. These patients do not require supplemental oxygen and are at high risk of progressing to severe illness.
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However, the Korea Exchange stated that the application for approval of the clinical trial drug does not guarantee the final approval decision by the regulatory authorities. There is a possibility that the results during the approval review process may not meet expectations, and accordingly, the company may change or abandon its commercialization plans.
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