By IDSE News Staff
The FDA has withdrawn the emergency use authorization for sotrovimab (Xevudy, GSK/Vir) to treat COVID-19 due to lack of effectiveness against the new omicron BA.2 subvariant, which is now causing more than 72% of cases in the United States.
The FDA has been limiting the authorization of sotrovimab for the treatment of COVID-19 in recent weeks as the number of BA.2 subvariant cases continue to rise across the United States. The FDA detailed sotrovimab should not be used for the treatment of COVID-19 in either adults or children.
As of April 5, the CDC estimates the omicron subvariant accounted for over 50% of all COVID-19 cases reported in the Health and Human Services U.S. regions. Data provided by the FDA showed the authorized dose of sotrovimab was inadequate in mitigating the health risks of the new subvariant. No beneficial reactions were observed in treatment with sotrovimab for patients hospitalized with COVID-19.
The FDA urged doctors and other medical providers to consult the list of approved or authorized treatment options and choose appropriately for their patients. Therapies including bebtelovimab, molnupiravir (Lagevrio, Merck), nirmatrelvir (Paxlovid, Pfizer) and remdesivir (Veklury, Gilead) are expected to be effective against the BA.2 subvariant.
Updates will be provided by the FDA as they continue to monitor the BA.2 subvariant in the United States.
—From FDA press materials
