FDA authorizes Vir-GSK antibody as variants threaten Eli Lilly mAb

The FDA has authorized the Covid-19 monoclonal antibody treatment from Vir and GlaxoSmithKline, adding another potent treatment option as the pandemic continues to rage in many corners of the world and as new variants threaten to render one of two rival approaches obsolete.

The EUA comes after Vir’s antibody proved 85% effective at preventing hospitalization in high-risk, newly diagnosed Covid-19 patients — numbers that rival or exceed those posted in pivotal trials by the antibody combos from Regeneron and Eli Lilly. Lilly’s combo, though, has already been taken out of use in two states, Illinois and Massachusetts, as it proved ineffective again a new variant. On Wednesday, it was paused in six other states: Arizona, California, Florida, Indiana, Oregon and Washington.

By contrast, Vir says their single antibody can neutralize each of the variants scientists suspect are proliferating, pointing to both published and unpublished data. It was originally isolated from a survivor of the SARS epidemic and was selected by Vir early in the pandemic for its ability to broadly neutralize most of the viruses in this family of the coronaviruses. Vir founder and venture capitalist Bob Nelsen argued throughout the pandemic that, unlike rivals, their antibody was likely to continue to work even after the virus mutated.

The antibody “has demonstrated, in vitro, that it retains activity against all known variants of concern, including the emerging variant from India,” CEO George Scangos said. “I believe that sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially for future coronavirus outbreaks, as well.”

Still, the exact impact Vir’s antibody will have on the pandemic remains unclear. Even before vaccines were widely available, antibody treatments were not widely used in the US, despite their potent ability to prevent hospitalization and death. Scangos has talked about the potential to deploy the drug around the world, but although Vir promised into late 2020 that they would have millions of doses available in 2021, a GSK spokesperson declined to say how many are now ready.

They also indicated that the antibody, known as sotrovimab, would take a bit of time to roll out.

“We are working to make sotrovimab available to appropriate patients in the US in the coming weeks now that it has been granted EUA,” they said.

For GSK, the EUA is likely to be immaterial, given their modest, 25% share of the profits, the fall in US cases and the limited uptake antibodies have had so far, SVB Leerink’s Geoffrey Porges wrote to investors. For Vir, however, he argued the antibody provides proof-of-principle for their platform, bringing them to commercial stage far faster than anticipated when they launched in 2016, and could even provide a substantial cash windfall.

With a lower dose and faster infusion times (30 minutes) than Regeneron or Lilly, he said, Vir’s antibody could even “catalyze more widespread use of these potentially life-saving medicines.”

Unlike the other mAbs, which the US government purchased and distributed, this one from Vir and GSK will hit the open market without such help. The spokesperson said they would price the drug at a rate similar to what Lilly and Regeneron charged the government per dose.