The Food and Drug Administration on Wednesday granted emergency-use approval to a monoclonal antibody therapy that researchers think is effective against the B.1.617.2 coronavirus variant discovered in India.
The move allows sotrovimab, which is developed by GlaxoSmithKline and Vir, to be administered on most coronavirus patients above the age of 12 who doctors think are at risk of hospitalization or death. The U.S. regulator, which has granted emergency-use authorization to two other antibody treatments for covid-19, said that there was no demonstrated benefit on patients already ill enough to be in hospital.
Interim results from a Phase 3 trial suggest sotrovimab can reduce the risk of hospitalization or death by 85 percent. The FDA decision comes a week after a European Medicines Agency committee concluded that sotrovimab could be used for similar categories of patients.
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