FDA withdraws novel coronavirus treatment authorization for GlaxoSmithKline’s Sotrovimab therapy

2022-07-30 0 By

The US Food and Drug Administration (FDA) said on April 5 that The antibody therapy Sotrovimab from GlaxoSmithKline (GSK) and Vir Biotechnology is no longer authorized for COVID-19 treatment in the US due to an increase in cases caused by the omicron BA.2 subvariant.The data showed that Sotrovimab therapy had little effect on the BA.2 subvariant.Vir said the two companies are preparing to support data on higher doses of Sotrovimab for the BA.2 subvariant, expect to start two trials in the second quarter of this year, and plan to file for full approval of the drug in the second half of this year.On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted contraindicated use authorization for Sotrovimab as a novel coronavirus neutralizing antibody therapy for mild and moderate symptoms in people 12 years of age and older.