The US Food and Drug Administration (FDA) has approved an emergency use authorisation for Eli Lilly’s monoclonal antibody bamlanivimab in high-risk COVID-19 patients.
Bamlanivimab is now available under emergency use for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older who are at high risk of progressing to severe COVID-19 and/or hospitalisation.
In a statement, Lilly said that bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within ten days of symptom onset.
The emergency approval is supported by data from Lilly’s BLAZE-1 study – a phase II study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting.
In this study, patients treated with bamlanivimab showed a reduced viral load and rates of symptoms and hospitalisation.
In addition, the frequency and types of adverse events were similar between bamlanivimab and placebo in the BLAZE-1 study, with the majority being mild to moderate in severity.
Despite the EUA, bamlanivimab remains an investigational drug and has not been approved under a Biologics Licence Application (BLA). Further evaluation of its safety and efficacy is ongoing across a number of patient populations impacted by COVID-19.
"This emergency authorisation 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 chief executive officer.
"The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most,” he added.