"The recent increase in COVID-19 cases has caused a substantial rise in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories. "Lilly developed bamlanivimab and etesevimab for administration together, in anticipation of variants such as the highly contagious Delta variant, which currently accounts for more than 98 percent of all identified COVID-19 cases in the U.S."
Pseudovirus and authentic virus studies demonstrate that bamlanivimab and etesevimab together retained neutralization activity against the Alpha and Delta variants. On September 2nd, the Office of the Assistant Secretary for Preparedness and Response (ASPR), alongside the U.S. Food and Drug Administration (FDA), resumed the shipment and distribution of bamlanivimab and etesevimab administered together.
The purchase was funded by the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response through Department of Defense contract number W911QY21D0012.
Bamlanivimab and etesevimab together are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
U.S. Govt. to Purchase Additional Doses of REGEN-COV Antibody Cocktail