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Tuesday, September 27, 2022

The Food and Medication Administration (FDA) has suspended the use of a Glaxo antibody drug in the United States because an Omicron subvariant has spread

Federal authorities said that they were halting the use of a monoclonal antibody medicine known as sotrovimab in the treatment of high-risk Covid-19 patients in the United States because it was unlikely to be effective against the Omicron subvariant known as BA.2, according to the announcement.

BA.2 is a highly transmissible virus that has emerged as the dominant strain in the United States, four months after it was originally discovered there. BA.2 was assessed to have been responsible for around 72 percent of new coronavirus infections in the United States for the week ending April 2 by the Centers for Disease Control and Prevention on Tuesday.

Shipments of sotrovimab were temporarily halted in late March to eight states in the Northeast and two territories — Puerto Rico and the United States Virgin Islands — because BA.2 had grown prevalent sooner than it had elsewhere in the nation.

Doctors treating high-risk patients may still utilise bebtelovimab, a monoclonal antibody medicine developed by Eli Lilly, which is another kind of monoclonal antibody. There are also three antiviral medications that have been demonstrated to be effective against BA in laboratory tests.2.

Federal regulators banned the use of two additional antibody medicines, from Eli Lilly and Regeneron, that were extensively used during the Delta spike last year because they were not effective against BA.1. The restrictions were implemented in January. They are also not anticipated to interfere with BA.2’s operations.

According to Sotrovimab’s manufacturers GlaxoSmithKline and Vir Biotechnology, laboratory testing revealed that the drug’s authorised dosage was insufficiently effective against BA.2. This finding was consistent with findings from independent researchers who had previously concluded that the drug’s authorised dosage was insufficiently effective against BA.2. The businesses said that they were prepared to submit data to authorities in order to obtain authorisation for a higher dosage of the drug that they hoped would be effective against BA2.

Jonathan James
I serve as a Senior Executive Journalist of The National Era
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