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Celltrion Healthcare: Celltrion Group meldet positive Wirksamkeits- und Sicherheitsdaten aus der globalen klinischen Phase-II/III-Studie mit dem COVID-19-Behandlungskandidaten CT-P59

Celltrion Healthcare: Celltrion Group meldet positive Wirksamkeits- und Sicherheitsdaten aus der globalen klinischen Phase-II/III-Studie mit dem COVID-19-Behandlungskandidaten CT-P59
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

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Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59

Celltrion Healthcare
Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59
Wednesday, January 13, 2021 3:52PM IST (10:22AM GMT)

CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over
CT-P59 (40mg/kg) treated patients reported a significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo
A significant reduction of viral load compared to placebo was reported at Day 7 in patients treated with CT-P59; with CT-P59 receiving a positive safety profile and no drug-related serious adverse events reported ....

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Celltrion Healthcare: Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59

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CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over
CT-P59 (40mg/kg) treated patients reported a significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo
A significant reduction of viral load compared to placebo was reported at Day 7 in patients treated with CT-P59; with CT-P59 receiving a positive safety profile and no drug-related serious adverse events reported
The preclinical data of CT-P59 against SARS-CoV-2, demonstrating a 100-fold reduction in viral load of SARS-CoV-2 and improved recovery time in animal models has been published in Nature Communications journal ....

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Celltrion beantragt bedingte Marktzulassung für den COVID-19-Behandlungskandidaten CT-P59 beim koreanischen MFDS

Celltrion beantragt bedingte Marktzulassung für den COVID-19-Behandlungskandidaten CT-P59 beim koreanischen MFDS
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

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Celltrion Submits Application for Conditional Marketing Authorisation of Its COVID-19 Treatment Candidate CT-P59 to the Korean MFDS

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Celltrion submitted today an application for Conditional Marketing Authorisation of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate to the Korean Ministry of Food and Drug Safety (MFDS)
Celltrion plans to submit Emergency Use Authorisation (EUA) to the U.S. FDA and Conditional Marketing Authorisation (CMA) to theEuropean Medicines Agency (EMA) for CT-P59 in the coming months
Celltrion successfully completed its global clinical trial of CT-P59, meeting objectives of clinical endpoints; top-line data to be announced in the first half of 2021
Celltrion Group has submitted today a formal Application for Conditional Marketing Authorisation (CMA) to the Korean Ministry of Food and Drug Safety (MFDS). This submission is based on the data from global Phase II/III clinical trial of CT-P59, meeting objectives of clinical endpoints. ....

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