U.S. drug regulators have shifted language on two monoclonal antibody medicines because of emerging subvariants of the Omicron virus variant.
The Food and Drug Administration (FDA) in recent days stipulated that an antibody treatment from GlaxoSmithKline and Vir Biotechnology cannot be used in regions where COVID-19 cases are likely to be caused by a variant “non-susceptible” to the drug.
At this time, sotrovimab, the treatment, is still authorized in every U.S. region “until further notice,” the agency says.
GlaxoSmithKline and Vir didn’t respond to requests for comment.
The FDA appears to be preparing for the event that more studies show decreased resistance to the subvariant.
A spokesman for the agency told The Epoch Times that the change gives the FDA “flexibility” to make sure sotrovimab is only administered in places where the treatment “is likely to provide benefit” to recipients.
The shift also aligns the authorization for sotrovimab with updated language for the other monoclonals the FDA has authorized.
According to a federally-run genomic surveillance program, BA.2 was responsible for 1 percent of cases in the United States during the week ending on Feb. 5. Another Omicron subvariant, B.1.1.529, was pegged as causing about 30 percent of cases in the country.
The authorized regimen was 150 milligrams of each of the two antibodies, tixagevimab and cilgavimab. It’s now 300 milligrams each.
Patients who received the previously authorized dosage should get an additional dose of 150 milligrams of each of the antibodies as soon as possible to ensure maximum protection, according to the FDA.
Evusheld, made by AstraZeneca, is authorized to prevent CCP virus infection in people with compromised immune systems.
AstraZeneca didn’t respond to a request for comment.