GSK and Vir Seek FDA Nod for Intramuscular Version of COVID-19 Antibody
GlaxoSmithKline (GSK) and Vir Biotechnology have developed an intramuscular version of their investigational monoclonal antibody infusion, sotrovimab, for the early treatment of COVID-19 and are asking the FDA to expand the drug’s Emergency Use Authorization (EUA) to include it.
Delivering the drug via a shot in the arm will make its administration much easier than requiring patients to come to a hospital or infusion center for an infusion.
The two companies announced that they have submitted an application requesting an amendment to the drug’s original EUA, which was granted in May 2021.
Under the current EUA, sotrovimab can be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years old and up with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19.
The submission to add the shot-in-the-arm version of sotrovimab to the EUA is based on a phase 3 noninferiority trial in which intramuscular administration of sotrovimab in 376 patients was noninferior and offered similar efficacy to IV administration in 378 patients for the early treatment of mild-to-moderate COVID-19 in high-risk, nonhospitalized adults and adolescents.
Low rates of serious adverse events were observed in the headline data, the companies said.
Also last week, GSK and Vir announced that the U.S. government amended its November 2021 purchase agreement with the companies to add 600,000 more doses of sotrovimab to be delivered throughout the first quarter of 2022. The amended agreement includes an option for the government to buy more in the second quarter of this year (DID, Jan. 12). — Suz Redfearn