On April 5, the U.S. government halted all shipments of GlaxoSmithKline’s IV drug for COVID-19, known as sotrovimab, and advised all health care providers not to use the drug.
The Food and Drug Administration (FDA) announced the decision on April 5, citing that it is likely not effective against the BA.2 omicron subvariant that now accounts for most U.S. cases.
The decision was expected as the FDA had already restricted the drug’s use in the Northeast and other regions where the BA.2 version of omicron became dominant.
Initially, doctors in eight states were told by the FDA to stop administering sotrovimab to COVID-19 patients on March 27. Several days later, the FDA expanded the notice to fourteen additional states, which essentially revoked the emergency use authorization it granted in 2021.
Now, with the April 5 decision, the monoclonal therapy “is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 subvariant,” the FDA said in a statement.
The Centers for Disease Control and Prevention (CDC) said on April 5 that BA.2 accounts for 72% of all COVID-19 cases.
According to testing done by the FDA, sotrovimab is 16 times less effective against BA.2. As a result, the authorized dose is likely ineffective against the subvariant, the FDA said in a recently updated fact sheet.
Since last fall, the federal government has purchased nearly $2 billion worth of Glaxo’s drug, shipping out more than 900,000 doses to U.S. states.
Around 16,600 doses were allocated to be given out last week, down from over 50,000 per week in previous weeks.
The decision leaves doctors and hospitals with just one antibody still authorized by the FDA for use against routine COVID-19 cases: bebtelovimab, a monoclonal therapy from Eli Lilly.
Medical providers can also prescribe antiviral pills that are still effective against omicron’s subvariants, mainly attacking the virus’s signature spike protein. Merck’s molnupiravir, Gilead’s remdesivir, or Pfizer’s paxlovid are all considered “effective” if they are taken early enough, according to the COVID-19 Treatment Guidelines Panel.
GlaxoSmithKline and Vir Biotechnology, which make sotrovimab, have said they have data that suggests the drug does contain neutralizing activity against BA.2.
After the FDA first ordered providers in some states to stop using the medicine, the companies said they were preparing data “in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and will be sharing these data with regulatory and health authorities around the world for discussion.”
