FDA halts the use of GSK's Covid-19 drug completely as BA.2 subvariant blankets the country
It only took the Omicron BA.2 subvariant three business days to go from shutting down GlaxoSmithKline and Vir Biotechnology’s Covid-19 treatment sotrovimab in 22 states, as of last Friday, to the FDA completely shutting off use of the monoclonal antibody nationwide on Tuesday afternoon.
The decision was made as the CDC now estimates that the proportion of Covid-19 cases caused by BA.2 is above 50% nationwide.
“Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant,” the FDA said in a statement.
While Omicron and its subvariant haven’t strained the health system like previous variants, at least so far, they have eliminated the use of several key drugs from the US armamentarium of Covid treatments.
But GSK and Vir made clear on Tuesday that sotrovimab is far from done. In addition to preparing to submit new data to the FDA to support a higher dose of sotrovimab to treat the BA.2 subvariant, the companies are also still moving ahead with their plans to submit for a full FDA approval for sotrovimab in the second half of this year.
The pair also still expect to manufacture approximately 2 million doses in the first half of 2022, and additional doses in the second half of the year.
They also still expect to commence two Phase III trials this quarter, according to a Vir SEC filing, to assess the use of sotrovimab in uninfected immunocompromised patients to determine whether sotrovimab can prevent symptomatic Covid infection.
One trial is a platform trial, and the other is a company-sponsored trial, known as COMET-STAR, although the primary endpoints for both are the incidence of symptomatic PCR-confirmed Covid-19. Vir said COMET-STAR results are still expected to come as early as the second half of this year, while initial data from the UK’s RECOVERY Trial, which is evaluating sotrovimab among patients hospitalized with Covid in the UK, is also expected in the second half of 2022.
But the loss of sotrovimab right now in the US means the landscape for Covid-19 treatments continues to dwindle, with Eli Lilly’s bebtelovimab serving as the last remaining mAb.
Since last September, the US bought almost $2 billion worth of sotrovimab courses, according to BARDA, and shipped more than 912,000 courses to states (as of Sunday), according to the Assistant Secretary for Preparedness and Response. Vir said it expects to recognize over $1 billion in sotrovimab collaboration revenues in the first half of this year.
Three other mAbs entered the graveyard of Covid-19 treatments previously as they were halted due to waning effectiveness against the dominant strain, including two blockbusters from Eli Lilly (bamlanivimab/etesevimab and bamlanivimab) and one blockbuster combo mAb from Regeneron (casirivimab/imdevimab).
On the positive side: More than $1 billion of bebtelovimab has been acquired so far, and early data suggest it will still stand up to BA.2.
On the negative side: Congress has yet to finalize additional funds for acquiring more mAbs from Lilly, AstraZeneca’s prophylactic mAb, and antiviral pills from Pfizer and Merck to treat Covid-19.
An agreement for $10 billion in new funds has been agreed to in principle, but $5 billion of that is likely devoted to paying for the next round of Pfizer’s Paxlovid.