Lilly’s monoclonal antibody is the first to be authorized for use in treating COVID-19
Bamlanivimab or LY-CoV555, a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2, is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.
The single antibody treatment, the first monoclonal antibody to be authorized for use in treating COVID-19, must be infused in a hospital or other health care setting.
The US government will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs for the medication.
"While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo," said the FDA.
The antibody is one of the first products of Lilly’s ongoing collaboration with Abcellera Biologics Inc.
Lilly advises that the treatment be given as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
"This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," said David A Ricks, Lilly's chairman and CEO.
Emergency use authorization
The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. The authorization is temporary and does not replace the formal review and approval process.
Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA), says Lilly.
Evaluation of its safety and efficacy is ongoing across a range of patient populations impacted by COVID-19. Data from these studies will be used to support a future BLA submission involving bamlanivimab, said the company.
Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020, for use around the world through early next year. Beginning in Q1 2021, it said the supply of its antibody therapy will increase substantially, as additional manufacturing resources come online throughout the year.
Insufficient evidence on using antibody in hospitalized patients
Recent data showed that the drug does not appear to help those with severe cases of COVID-19, but trials continue for milder cases.
Mid-way through October, the US company announced that enrollment in one of the trials on the neutralizing antibody – the ACTIV-3 clinical trial, which was evaluating the treatment in hospitalized COVID-19 patients – was on hold. That ACTIV-3 clinical trial was being run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
Then late last month, Lilly revealed that, based on an updated dataset from the trial reviewed on October 26, no additional COVID-19 patients in this hospitalized setting would receive bamlanivimab.
“This recommendation was based on trial data suggesting that bamlanivimab is unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease. In this updated dataset, differences in safety outcomes between the groups were not significant.”
The company said all other studies of bamlanivimab remain ongoing.
“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.”