COVID roundup: GSK, Vir seek to extend EUA for Xevudy to include intramuscular admin  

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Vir Biotechnology Inc. (NASDAQ:VIR) have asked FDA to extend the EUA for Xevudy sotrovimab to include its intramuscular administration following clinical data showing that IM administration of the mAb is non-inferior to IV administration, for which sotrovimab was granted an EUA on May 5. IM administration is easier than IV, and FDA’s extension of the EUA would allow Xevudy to more effectively compete with Paxlovid nirmatrelvir/ritonavir from Pfizer Inc. (NYSE:PFE), which is administered orally and received an EUA on Dec. 22. GSK and Vir showed that the efficacy of Xevudy could be maintained against the Omicron variant of SARS-CoV-2 last December.

Separately, EMA is evaluating an application from Pfizer seeking conditional marketing authorization for Paxlovid for mild-to-moderate COVID-19 in adults and adolescents at risk of progressing to severe infection. ...