Bamlanivimab plus etesevimab combination is indicated for the treatment of mild to moderate Covid-19 in patients aged 12 and older
Eli Lilly and Company's Corporate Center in Indianapolis, Indiana. (Credit: Momoneymoproblemz/Wikipedia.)
Lilly has secured the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for the combination of bamlanivimab (LY-CoV555) 70 mg and etesevimab (LY-CoV016) 140 mg to treat Covid-19.
The FDA authorisation indicated bamlanivimab plus etesevimab as treatment for mild to moderate Covid-19 in patients aged 12 and older, at risk for progressing to severe Covid-19 or hospitalisation
Bamlanivimab and etesevimab are advised to be administered together, through a single intravenous infusion soon after receiving a positive result from Covid-19 test, within 10 days of symptom onset, said the company.
Lilly chief scientific officer and Lilly Research Laboratories president Daniel Skovronsky said: “Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat Covid-19.
“Bamlanivimab alone under emergency use authorisation has already provided many people with an early treatment option that could prevent hospitalisations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit.
“Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world.”
Bamlanivimab is a recombinant, neutralising human IgG1 monoclonal antibody (mAb) designed to act against the spike protein of SARS-CoV-2.
Etesevimab is a recombinant human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain.
The US regulator authorised infusion times of 16 minutes for bamlanivimab alone and 21 minutes for bamlanivimab and etesevimab together, which significantly reduced from the previous time of 60 minutes.
The infusion times were reduced based on feedback received from front-line nurses and doctors, to decrease the burden on the healthcare system.
FDA authorised the combination treatment based on data from the Phase 3 BLAZE-1 trial, announced on 26 January 2021.
The Phase 3 data showed that bamlanivimab and etesevimab together reduced the risk of Covid-19 hospitalisations and death by 70%.
Also, the treatment using bamlanivimab and etesevimab resulted in outcomes that are consistent with the reduction in risk of hospitalisation or ER visits observed with bamlanivimab alone.
Nausea on the day of infusion was the most common adverse event, reported by patients receiving bamlanivimab and etesevimab together, compared to placebo.
FDA Centre for Drug Evaluation and Research acting director Patrizia Cavazzoni said: “Today’s action, which provides another treatment for Covid-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options health care providers can use to fight this pandemic.
“The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralising antibodies for the treatment of Covid-19 in certain patients.
“As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness.”