While vaccines play a crucial role in the fight against COVID-19, treatments are needed to limit the need for hospitalization, speed recovery times, reduce mortality, and alleviate long-lasting symptoms or prolonged COVID. In this sense, there are two new anti-Covid drugs authorized by the EMA.
The EMA’s Committee for Human Medicines (CHMP) has recommended authorizing Ronapreve (casirivimab / imdevimab) and Regkirona (regdanvimab) for COVID-19.
The Committee recommended to authorize Ronapreve for the treatment of COVID-19 in adults and adolescents (from 12 years and with a minimum weight of 40 kilograms). Which do not require supplemental oxygen and are at higher risk of their disease getting worse.
IN THIS WAY THEY CAN BE USED
Ronapreve can also be used to prevent COVID-19 in people 12 years of age and older who weigh at least 40 kilograms. The company that applied for Ronapreve’s authorization was Roche Registration GmbH.
Regarding Regkirona, the Committee recommended authorizing the drug for the treatment of adults with COVID-19. Both of whom do not require supplemental oxygen and are also at increased risk of their illness becoming severe. Regkirona’s applicant was Celltrion Healthcare Hungary Kft.
How do the two new drugs work?
Study data for Ronapreve
A main study involving COVID-19 patients who did not need oxygen and were at increased risk of their illness getting worse. It showed that Ronapreve treatment at the approved dose resulted in fewer hospitalizations or deaths compared to placebo (a dummy treatment).
Overall 0.9% of patients treated with Ronapreve (11 of 1192 patients). They were hospitalized or died within 29 days of treatment compared to 3.4% of placebo-treated patients (40 of 1,193 patients).
Another main study looked at the benefits of Ronapreve for preventing COVID-19 in people who had close contact with an infected household member. Ronapreve was found to be effective in preventing people from becoming infected and developing symptoms after contact.
Among people who tested negative for SARS-CoV-2 after contact. Fewer people who received Ronapreve developed symptoms within 29 days of the test results compared to people who received placebo. (1.5% (11 of 753) for Ronapreve compared to 7.8% (59 of 752 people) for placebo).
Ronapreve was also found to be effective in preventing symptoms in infected people. Among people who tested positive for SARS-CoV-2 after contact. 29% of people (29 out of 100) who received Ronapreve developed symptoms compared to 42.3% of people (44 out of 104) who received a placebo.
Study data for Regkirona
A main study in COVID-19 patients showed that Regkirona treatment resulted in fewer patients requiring hospitalizations or oxygen therapy or dying compared to placebo.
Among patients at higher risk of disease worsening, 3.1% of Regkirona-treated patients (14 out of 446) were hospitalized, required supplemental oxygen, or died within 28 days of treatment compared to 11, 1% of patients treated with placebo (48 of 434).
The safety profile of both drugs was favorable with a small number of infusion-related reactions, and the CHMP concluded that the benefits of the drugs outweigh their risks for the approved uses.
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