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EMA starts rolling review of Celltrion’s COVID-19 treatment

Regdanvimab, marketed under the name 'Regkirona' (Celltrion)
Regdanvimab, marketed under the name 'Regkirona' (Celltrion)
European Medicines Agency said Wednesday, local time, that it has started a “rolling review” of data on South Korean company Celltrion’s monoclonal antibody regdanvimab.

Regdanvimab, also known as CT-P59, is being developed by Celltrion for the treatment of COVID-19.

A rolling review refers to an on-the-roll evaluation system that accepts data as they come from ongoing research. This form of evaluation is enforced during public health emergency, for a more time-efficient assessment of promising drugs.

“While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review,” the EMA said.

Celltrion has finished a global clinical phase 2 trial of regdanvimab and has gained the Korean drug authority’s emergency approval to use the drug in the country, conditional on phase 3 trial result submission within 2021.

The company is seeking similar approvals in the US and in Europe.

Regdanvimab prevents hospitalization of COVID-19 confirmed patients by interfering with the virus‘ entrance to their human cells.

Celltrion said in a separate press release Thursday that it is ready for immediate global distribution of regdanvimab upon approval.

“We will do our best to supply regdanvimab as fast as possible, to end the COVID-19 global pandemic,” said Celltrion.

Celltrion is undergoing clinical phase 3 trial in some 10 countries targeting 1,200 patients displaying mild and moderate symptoms.

The company is also developing another cocktail antibody for the UK and South Africa variant.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)
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