US FDA Approves Casirivimab, Imdevimab For Treating Mild-To-Moderate Covid Symptoms

NEW DELHI, 23 NOV 2020:

The US Food and Drug Administration (US FDA) has issued an emergency use authorisation (EUA) for a combination of drugs--casirivimab and imdevimab--to be administered together for treatment of mild to moderate covid-19 symptoms in adults and paediatric patients who are 12 years of age or more, weighing at least 40 kilograms and at high risk for progressing to severe covid-19.

In a statement, the US FDA said in casirivimab and imdevimab must be administered together by an intravenous (IV) infusion.

The antibody cocktail is from Regeneron Pharmaceuticals Inc.

Clinical evidence from outpatient trial suggests the treatment therapy's greatest benefit was when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

The safety and effectiveness of this investigational therapy for use in treatment of covid-19 continues to be evaluated, the US regulator said.

It, however, added that casirivimab and imdevimab are not authorised for patients who are hospitalised due to covid-19 or require oxygen therapy due to covid-19.

“A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to covid-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with covid-19 requiring high flow oxygen or mechanical ventilation," the FDA warned.

Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’s attachment and entry into human cells. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.

The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that casirivimab and imdevimab administered together may be effective in treating patients with mild or moderate covid-19, the US FDA statement said.

“We will continue to facilitate the development, evaluation and availability of covid-19 therapies," said Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research.

The FDA also said there are possible side effects of casirivimab and imdevimab such as anaphylaxis and infusion-related reactions, fever, chills, hives, itching and flushing.Livemint