FDA cuts off use of GSK's Covid treatment in almost half of the US as BA.2 spreads
With the rise of the Omicron sister variant BA.2, GlaxoSmithKline and Vir Biotechnology’s crucial monoclonal antibody — one of only two mAbs still being shipped by the US government to states to treat Covid-19 — has finally met its match, and almost half of all US states have now lost access to the crucial mAb as it’s not as effective against the new strain.
ASPR on Friday said it paused distribution of GSK and Vir’s sotrovimab to six states across the Midwest (Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin), and eight states in the West (Arizona, California, Hawaii, Nevada, Alaska, Idaho, Oregon and Washington), as well as five territories — the Commonwealth of the Northern Mariana, Guam, American Samoa, Republic of Palau and the Republic of the Marshall Islands.
This halt is in addition to a previous halt from late last month across the Northeast, as ASPR said sotrovimab will no longer be used in eight states and two US territories.
Sotrovimab still remains authorized in the US where the CDC estimate for the proportion of the BA.2 variant remains below 50%. FDA says it will continue to monitor BA.2 nationwide and may revise the authorization further.
“Health care providers in regions where sotrovimab remains authorized should strongly consider the use of other approved or authorized products, and monitor the frequency of BA.2 in their region as they choose appropriate treatment options for patients,” the FDA said on Friday.
On top of the loss of sotrovimab across 22 states, and likely more in the near future, Congress has yet to finalize additional funds for acquiring more mAbs from Eli Lilly and AstraZeneca and antiviral pills from Pfizer and Merck to treat Covid-19. An agreement for $10 billion in new funds, with $5 billion devoted to treatments, according to Sen. Roy Blunt (R-MO), is still in the works.
Since last September, the US has 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. Whereas the other mAb that’s still being shipped to states, Eli Lilly’s bebtelovimab, has seen just over 300,000 courses shipped, more than $1 billion of the drug has been acquired. Early data suggest bebtelovimab will still stand up to BA.2 too, according to BARDA.
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).
Regeneron said in an SEC filing recently that it has completed or discontinued dosing with its mAb combo in all treatment and prevention studies. However, the company said it continues to develop “next gen” antibodies that are active against Omicron and other variants of concern, with new clinical development in the coming months.
Meanwhile, for those looking for Covid-19 treatments: ASPR has now created a web-based site locator to make it easier to find its “Test to Treat” locations, which is a new federal program where people can go to a local pharmacy, get tested for Covid-19, and receive treatment on site if the test is positive.