Given together, bamlanivimab and etesevimab have an emergency use authorization from the FDA to both treat COVID-19 and prevent infection in those who have been exposed.
Lilly has chosen Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions to dispense the infused medications bamlanivimab and etesevimab, also known as BAM. When combined, bamlanivimab and etesevimab is a monoclonal antibody treatment authorized for emergency use for the treatment of mild-to-moderate COVID-19.
The organizations have 21 locations throughout the United States and Puerto Rico. All locations are licensed to administer the REGEN-COV antibody treatment. A list of locations can be found here.
Amber Specialty and Hy-Vee were part of the original pilot program through a partnership with the U.S. Department of Health and Human Services and the National Home Infusion Association. The program provided treatment to patients across the country, primarily servicing long-term care facilities.
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2. Etesevimab is a recombinant fully human monoclonal neutralizing antibody that specifically binds to the SARS-CoV-2 surface spike protein receptor and can block the binding of the virus to the ACE2 host cell surface receptor. Given together, they have an emergency use authorization from the FDA to both treat COVID-19 and prevent infection in those who have been exposed.
The FDA expanded Eli Lilly’s emergency use authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis.
Related: FDA Expands EUA for Lilly’s COVID-19 Monoclonal Antibody
Lilly also announced an agreement for the U.S. government to purchase 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with about 200,000 doses expected to ship third quarter of 2021 and the remaining to be shipped in fourth quarter. This transaction is expected to generate about $330 million in revenue in the second half of 2021, according to a Lilly statement.
Amber Specialty and Hy-Vee were also chosen by Regeneron for the distribution of its monoclonal antibody treatment for COVID-19.
Related: Amber Specialty, Hy-Vee to Dispense Regeneron Monoclonal Antibody for COVID-19
FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
Read More
ICER Gives Cell Therapy for Post-Transplant Complications High Rating
Published: October 31st 2024 | Updated: October 31st 2024ICER has given tabelecleucel a rating of A, indicating the T cell therapy for Epstein-Barr virus related post-transplant lymphoproliferative disease has a high certainty of substantial net health benefit and would be cost-effective if priced between $143,900 and $273,700.
Read More