The U.S. FDA has recently issued an EUA (emergency use authorization) of casirivimab & imdevimab. These monoclonal antibodies will be jointly administered to treat mild to moderate COVID-19 disease among adults as well as pediatric patients of 12 years and older weighing at least 40 kg. The treatment will also be used in patients of 65 years and older with certain chronic conditions.

As per the clinical trial results, casirivimab and imdevimab were shown to reduce the risk of hospitalization and emergency room visits related to COVID-19 within 28 days of treatment. Several researches have also been evaluating the safety and effectiveness of this therapy.

However, the two monoclonal antibodies have not been authorized for use among the hospitalized COVID-19 patients that require oxygen therapy, as the therapy is shown to be associated with adverse clinical outcomes among this patient base. The two antibodies are specifically administered against the spike protein of SARS-CoV-2, and were designed to block the virus entry and attachment to the human cells.

The recent EUA is in line with the data collected from a randomized, placebo-controlled, double-blind clinical study conducted among 799 non-hospitalized adults. The primary endpoint of the trial was the time-weighted average change in the viral load from baseline. The most crucial evidence about the effectiveness of the two antibodies came from its predefined secondary endpoint of the COVID-19 related, medically attended visits within 28 days of treatment.

Under the recent EUA, various fact sheets with key information about the usage of casirivimab and imdevimab must be made available to patients, caregivers, and healthcare providers. The fact sheets include drug interactions, potential side-effects, and dosing instructions. Possible adverse events of these antibodies include flushing, itching, hives, chills, fever, and anaphylaxis & infusion-related reactions.

The EUA had been issued to a biotechnology company, Regeneron Pharmaceuticals.

Source credit:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19