FDA Extends Shelf-Life of Sotrovimab to 18 Months

The FDA has extended the allowed shelf-life of GSK’s COVID-19 antibody treatment sotrovimab from 12 months to 18 months, speculating that it could prove useful for treating future unknown variants of the virus.

The agency granted an Emergency Use Authorization for the monoclonal antibody in May 2021 but withdrew it on April 5 of this year because the treatment is less effective against subvariants of the SARS-CoV-2 virus that are currently causing increased COVID-19 infections.

Despite the drug not being currently authorized for use in the U.S., the Department of Health and Human Services recommended that the product be kept available for an extra six months for possible use against new variants or subvariants that could become dominant in the U.S.