The antibody therapy combination has been granted FDA EUA, to treat mild to moderate Covid-19 or for post-exposure prophylaxis of Covid-19
Eli Lilly and Company's Corporate Center in Indianapolis, Indiana. (Credit: Momoneymoproblemz/Wikipedia.)
The US government has reached an agreement with Lilly to purchase additional doses of its antibody therapy comprising bamlanivimab and etesevimab, to treat Covid-19.
Under the terms of the agreement, Lilly will supply additional 614,000 doses of its antiviral therapy to the US, before 31 January 2022 for a total consideration of $1.29bn.
The pharmaceutical company has agreed to supply a minimum of 400,000 doses no later than 31 December 2021.
Earlier this year, the antibody therapy combination has been authorised for emergency use in the US to treat mild to moderate Covid-19 or for post-exposure prophylaxis of Covid-19.
Bamlanivimab is a recombinant, neutralising human IgG1 monoclonal antibody (mAb) designed to target the spike protein of SARS-CoV-2, preventing its entry into human cells.
The drug was created under collaboration between Lilly and AbCellera, which aimed at developing antibody therapies for the prevention and treatment of Covid-19.
It was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
Researchers at Lilly have developed the antibody three months after its discovery.
Etesevimab is a recombinant fully human monoclonal neutralising antibody, designed to specifically target the SARS-CoV-2 surface spike protein receptor.
It was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). Later, it was licensed by Lilly from Junshi Biosciences
Results from a Phase 2/3 study in people recently diagnosed with Covid-19 in the ambulatory setting (BLAZE-1) and a Phase 3 study of bamlanivimab at long-term care facilities (BLAZE-2) showed positive outcomes for the therapy.
Lilly said that the transaction will have an estimated impact of $840m of additional revenue and around 25 cents of additional earnings per share.
In a separate development, European Medicines Agency (EMA) has halted the rolling review of bamlanivimab and etesevimab for the treatment of Covid-19.
The company informed the agency that it was withdrawing from the review process.
EMA’s human medicines committee (CHMP) has been reviewing data on Lilly’s drug combination from March 2021, as part of a rolling review.
The company has submitted data during the rolling review process to advance the evaluation for obtaining marketing authorisation for the treatment.
EMA has also released advice for treating Covid-19 based on data from a clinical study, which supported the use of the antibodies at the national level before a marketing authorisation.