Pemgarda
The monoclonal antibody, called pemivibart (Pemgarda), is authorized for pre-exposure prophylaxis in adolescents and adults with moderate-to-severe immunocompromise, such as solid-organ transplant recipients and those with blood cancers. The drug is given as a 4,500-milligram intravenous infusion. The company had submitted its EUA request in early January.
The FDA based its EUA on clinical trials that suggested pemivibart had neutralizing activity against SARS-CoV-2 variants, including JN.1, which is currently dominant in the United States and abroad.
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