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Business & Regulation COVID-19, Standards & Regulation

R&R for an Anti-COVID Europe

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given the thumbs up to not one but two monoclonal antibody treatments for COVID-19. The mAbs in question are Roche’s Ronapreve and Celltrion’s Regkirona, which both received the nod after the CHMP evaluated data from studies that demonstrated how each treatment reduces hospitalization and deaths in patients.

The study on Ronapreve was conducted on COVID-19 patients who did not require oxygen and were at increased risk of their illness becoming severe. It was found that 11 out of 1,192 patients treated with the mAb died or were hospitalized within 29 days, compared with 40 deaths or hospitalizations out of the 1,193 patients who received placebo.

An additional study on Ronapreve, which assessed patients exposed to COVID-19 at home, found the mAb was effective in guarding against both infection and the progression of symptoms. Among those who tested SARS-CoV-2 negative, Ronapreve beat placebo, resulting in 11 out of 753 positive tests after treatment compared with the placebo’s 59 out of 752.

The study on Regkirona resulted in similar numbers. Among patients at risk of increasingly severe illness, 14 out of 446 treated with the mAb were hospitalized, required supplemental oxygen, or died within 28 days of treatment. Of 446 patients treated with placebo, 48 suffered the same negative outcomes.

The CHMP’s recommendations will now move up the ladder to the European Commission. Ronapreve has already received approvals in the UK, Japan and the US. Regkirona is currently approved in Brazil and in Celltrion’s “homeland” of South Korea.

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About the Author
Angus Stewart

Angus is Associate Editor of The Medicine Maker

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