Covid antibody therapy from Vir, Glaxo loses US authorisation

Bloomberg: A Covid-19 antibody treatment from Vir Biotechnology Inc and GlaxoSmithKline Plc lost its US authorisation as the therapy is unlikely to work against the dominant omicron BA.2 subvariant, regulators said.

The treatment, sotrovimab, is no longer authorised in any US state or territory, since the subvariant accounts for more than half of virus cases in all regions, the US Food and Drug Administration said in a statement. Last month, the agency limited use of the drug only in parts of the country where the subvariant dominated. Recent data suggested the treatment was less effective against BA.2 than other variants.

The move marks a stunning turn of events for sotrovimab, which just a few months ago was the rare antibody that continued to work against heavily mutated omicron while other treatments were rendered ineffective.

Glaxo shares fell less than 1% in early London trading. Vir slid 11% to close at $22.42 in New York.

Vir and Glaxo have said they’re preparing to submit data on a higher dose of sotrovimab and plan to share the findings with regulators around the world.

“As Covid-19 continues to evolve and new variants emerge, we expect that governments and health systems will continue to need a full and diverse arsenal of vaccine and therapeutic options to both prevent and treat patients,” the companies said in an emailed statement. “We’ll continue to work with them to ensure ongoing access to sotrovimab.”