- U.S. authorities on Tuesday withdrew their authorization of Vir Biotechnology and GlaxoSmithKline's COVID-19 antibody treatment after a subvariant of omicron became dominant in the country.
- The drug, sotrovimab, had proven effective against the original omicron variant, making Vir and GSK's antibody a go-to treatment for a time. But the drug appears less potent against a subvariant known as BA.2 that now accounts for more than 72% of all cases in the U.S.
- The Food and Drug Administration said doctors should instead use one of the treatments that are still authorized. They include Eli Lilly's newest antibody drug, bebtelovimab, and pills made by Pfizer and Merck & Co.
Drugmakers and regulators are trying to stay ahead of frequent mutations in the coronavirus that can disable once-effective treatments for COVID-19. The latest decision to withdraw the emergency clearance for sotrovimab completely came after the FDA twice limited the drug's use to specific regions that weren't yet host to the BA.2 subvariant.
Lilly and Regeneron were the first companies to win authorization of antibody therapies for COVID-19 and the medicines were initially quite effective. When former President Donald Trump contracted the virus in October 2020, he received Regeneron's drug.
The treatment picture changed with omicron, which could evade Lilly and Regeneron's medications. Officials then turned to the still-effective sotrovimab. The U.S. government bought up 600,000 doses, and demand around the world soared.
As of a few months ago, U.S. authorities were shipping about 50,000 doses of sotrovimab to states and territories every week. Shipments of Lilly's bebtelovimab quickly shot up to the same level after the drug's authorization in February. Distributions of both treatments decreased in recent weeks as supplies dwindled and authorities waited for new funds from Congress to buy more.
Vir and GSK plan to seek FDA authorization for a higher dose of sotrovimab they think can prove effective versus BA.2. And even as sotrovimab loses its emergency clearance, another company is trying to break into the treatment market despite doubts that its product works against omicron. Adagio Therapeutics said last week it's planning to ask the FDA to authorize its antibody treatment, known as adintrevimab.