Pharmaceutical agency reveals new antibody medication
In a recent update, the European Medicines Agency (EMA) has recommended the use of the antibody drug Casirivimab for COVID-19 patients with mild cases. This recommendation, published on Friday, comes amidst a significant decline in the global use of the drug combination, Casirivimab and Imdevimab, for mild COVID-19 cases.
Casirivimab, a human monoclonal antibody, is combined with Imdevimab, its active substance, in a fixed combination. This drug combination was initially used for mild to moderate COVID-19 cases, but its global use has been affected by viral mutations that reduce its neutralizing capability, limiting its clinical utility outside specialized or early outbreak contexts.
In the United States, patients who are hospitalized or require oxygen cannot receive Casirivimab. This restriction, along with diminished effectiveness against circulating SARS-CoV-2 variants, led to the US Food and Drug Administration (FDA) revoking the emergency use authorization of Casirivimab and Imdevimab in mid-2025.
Beyond the US, key markets profiled for monoclonal antibody therapies include Europe, Australia, parts of Asia, and the Middle East. Regulatory agencies in these regions have largely aligned with evidence showing reduced benefit for these antibodies against current virus strains.
Alternative monoclonal antibodies, such as tixagevimab plus cilgavimab, have gained preference for prophylaxis or treatment in some countries under conditional approvals. However, treatment guidelines continue to evolve dynamically as new variants emerge and vaccines remain primary prevention tools.
Pricing and accessibility data show considerable variation worldwide, with Casirivimab and Imdevimab being expensive compared to other COVID-19 treatments. No widespread generic or low-cost manufacturing has been established, constraining use in low- and middle-income countries.
In summary, beyond US restrictions, the use of Casirivimab and Imdevimab for mild COVID-19 is very limited globally, with many countries withdrawing or restricting use due to effectiveness concerns and variant resistance, alongside the availability of other treatments and vaccines.
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Other health-and-wellness therapies and treatments may be preferred over Casirivimab for mild COVID-19 cases in Europe, given the reduced benefit of monoclonal antibodies like Casirivimab against current virus strains, as suggested by the European Medicines Agency (EMA). Additionally, science continues to explore alternative monoclonal antibodies, such as tixagevimab plus cilgavimab, which are gaining preference in some countries for prophylaxis or treatment under conditional approvals.
