As Delta takes control, US resumes use of Lilly's Covid-19 mAb combo nationwide
A little more than two months after the US halted all shipments of Eli Lilly’s monoclonal antibody combo for the treatment of Covid-19 on a national basis, the FDA has decided that the use of the drug can resume across the country.
“Based on the most currently available data, bamlanivimab and etesevimab are now authorized in all U.S. states, territories, and jurisdictions,” the FDA said yesterday, noting in a fact sheet that the combo retained activity against the Delta variant. The combo had previously been pulled because it struggled to work against the Beta and Gamma variants, which are now no longer prevalent in the US.
The FDA added:
Based on in vitro assays that are used to assess the susceptibility of viral variants to monoclonal antibodies, bamlanivimab and etesevimab, administered together, are expected to retain activity against the Delta variant (B.1.617.2), which is now the dominant variant in the United States. The increase in prevalence of B.1.617.2 has been associated with a concomitant decrease in the frequency of identified variants that are expected to be resistant to bamlanivimab and etesevimab.
Shipments of the combo treatment resumed in some states in late August, according to Lilly, which praised the announcement. The company stood to lose about $375 million in sales due to the previous pause, according to one Wall Street analyst.
The news will also be welcomed by infusion sites, which have previously dealt with shortages of other mAbs to treat Covid-19, as an uptick of Delta cases continues to ravage the country.
The federal government has allocated almost 1 million courses of the various mAb cocktails through early March, according to federal data.
