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Drug safety agency advises conditional approval of Celltrion's COVID-19 treatment

All News 16:06 January 18, 2021

By Kim Han-joo

SEOUL, Jan. 18 (Yonhap) -- South Korea's drug safety agency said Monday its panel has advised the approval of pharmaceutical giant Celltrion Inc.'s COVID-19 treatment candidate on the condition of an ongoing phase-three clinical trial.

The firm earlier submitted an application for conditional marketing authorization of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, with the Korean Ministry of Food and Drug Safety. The approval would mark the country's first homegrown COVID-19 treatment.

This file image, provided by South Korea's pharmaceutical giant Celltrion Inc. on Dec. 29, 2020, shows the company's anti-COVID-19 monoclonal antibody treatment. (PHOTO NOT FOR SALE) (Yonhap)

Health authorities convened a panel of experts to review the safety and efficacy of CT-P59 and advised the authorization on the condition that Celltrion submit results of the global phase-three clinical trial.

Last week, Celltrion announced top-line results from its randomized and placebo controlled global phase-two clinical study, saying CT-P59 reduces recovery time and the chance of a severe case.

The result demonstrated that the treatment significantly reduced risk of COVID-19 related hospitalization and oxygenation without mortality.

When compared with placebo groups, CT-P59 treated-patients reported reduced progression rates to severe COVID-19 by 54 percent for mild-to-moderate patients and 68 percent for moderate patients aged 50 years or older.

The panel, however, said the study results, noticeably the data on virus reduction and mortality rate, were not statistically significant enough.

The panel further advised Celltrion to administer CT-P59 to adult COVID-19 patients whose oxygen saturation rate hovers above 94 percent, and those who do not need auxiliary oxygen treatment.

Celltrion earlier said it plans to conduct a global phase-three clinical trial, a pivotal part of the study, in more than 10 countries to obtain more comprehensive safety and efficacy results of CT-P59.

The company also plans to submit an application for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration and for Conditional Marketing Authorization to the European Medicines Agency (EMA) in the coming months.

CT-P59 takes the form of an intravenous injection that is directly injected into the vein for 90 minutes.

Earlier in the day, Prime Minister Chung Sye-kyun said the treatment could be used from early next month in antivirus activities in the field if the review process goes smoothly,

Experimental drugs under clinical trial are sometimes granted approval for emergency usage from the ministry in cases where diseases are life-threatening and there is no other treatment option. The approval requires three steps of advisory panel.


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