GlaxoSmithKline and Vir finally score $1B supply deal for COVID antibody—6 months after FDA nod

GSK
GlaxoSmithKline and Vir Biotechnology, which gained FDA approval for its COVID-19 antibody treatment in May, have finally scored a supply deal with the United States. (Eric Sagonowsky)

It was a long time coming but GlaxoSmithKline and Vir Biotechnology have finally secured a supply deal with the United States for their COVID-19 antibody treatment—six months after it scored an FDA emergency authorization.

The U.S. will pay $1 billion to expand access to sotrovimab throughout the country. While the green light for sotrovimab—known commercially as Xevudy—came in May, the therapy has been available in more than half of the states in the U.S., which were free to make separate deals to acquire it.

GSK said it will supply the contracted doses by Dec. 17. There is an option for the U.S. to purchase additional doses by March 2022.

GSK did not reveal how many doses are included in the agreement but said it has now secured contracts to sell more than 750,000 doses worldwide. Japan, Australia and Canada are among the countries that have inked supply deals for sovrotimab.

In July, the European Commission announced a purchase of up to 220,000 doses of sotrovimab, two months after it began a rolling review of the treatment. The therapy still has not been approved in Europe. Within the last week, Europe has endorsed the COVID-19 antibodies produced by Roche/Regeneron and Celltrion.

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“Monoclonal antibodies play an essential role in the treatment of certain patients with COVID-19,” Vir CEO George Scangos said in a release. “Given ongoing evidence, which demonstrates its ability to maintain activity against the tested circulating variants of concern, including Delta, we are confident sotrovimab will continue to be important in the fight against COVID-19.”

The news comes less than a week after GSK and Vir revealed that a more user-friendly intramuscular version of sovrotimab delivered similar efficacy to the infused version in a phase 3 trial.

In the U.S., sotrovimab is authorized for mild-to-moderate COVID-19 patients 12 and older who weigh at least 40 kg (88 pounds) and are at risk for progressing to a severe form of the virus. It was approved after a phase 3 trial showed sovrovimab reduced the risk of hospitalization and death by 79%.

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The deal comes as the U.S. appears on the verge of sanctioning potential game-changing oral COVID-19 treatments for the same patient population. An FDA advisory committee will discuss Merck and Ridgeback Biotherapeutics’ molnupiravir on Nov. 30. Pfizer’s COVID-19 tablet, Paxlovid, appears close behind in the regulatory process.