EMA recommends appro of MAb medicines for COVID-19
The European Medicines Agency has announced a much-anticipated recommendation for two COVID-19 medicines: Ronapreve (casirivimab/imdevimab) from Swiss pharma giant Roche (ROG: SIX), and Regkirona (regdanvimab) from Celltrion Healthcare Hungary, a part of South Korea’s Celltrion Healthcare (Kosdaq: 068270), for COVID-19.
The EMA’s human medicines committee (CHMP) recommended authorising Ronapreve for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.
With regard to Regkirona, the Committee recommended authorizing the medicine for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe.
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