Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says the federal government has given the company approval to resume shipments and distribution of its antibody therapies bamlanivimab and etesevimab. The company paused shipments in June as the company determined the efficacy against the Delta variant of COVID-19.
Lilly says the Delta variant currently accounts for nearly 96% of all COVID cases in the U.S. In the authorization to resume shipments, the U.S. Food and Drug Administration said, ”pseudovirus and authentic virus studies demonstrate that bamlanivimab and etesevimab together retained neutralization activity against the Alpha and Delta variants.”
Lilly says the prevalence of variants varies by state, region and country and can change quickly. “As variants continue to evolve and their patterns of transmission and prevalence shift, we will continue our work with governments and regulators worldwide to ensure our antibodies are available to appropriate patients,” said the company in a statement.”
In February, Lilly received Emergency Use Authorization for the combination as a treatment of mild- to moderate COVID-19 in pediatric patients and adults 12 years and older, who are at risk for a severe case.