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Lilly’s combination antibody expanded to children under 12

The FDA has expanded the emergency use for bamlanivimab with etesevimab for the treatment of and post-exposure prophylaxis against COVID-19 in high-risk children aged under 12

Eli Lilly

Since the start of the pandemic, Eli Lilly has focused ‘the full force of its expertise' on monoclonal antibody (mAb) treatments that neutralise the virus and was the first company to gain emergency authorisation in the US for bamlanivimab.

This success was followed in February this year by the authorisation of the combination of bamlanivimab with etesevimab for adults and children aged 12 and over.

Now, Lilly has scored another first with the announcement by the Food and Drug Administration (FDA) of an expansion of its emergency use authorisation for the mAb duo to include children under 12, based on data from a paediatric trial, BLAZE-1.

Administered together, bamlanivimab and etesevimab can now be given to adults and children including neonates for the treatment of mild to moderate COVID-19 or post-exposure prophylaxis in those who are at high risk for progression to severe disease, including hospitalisation or death.

“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention,” said Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorisation addresses the medical needs of this vulnerable population.”

Bamlanivimab – a recombinant, neutralising human IgG1 mAb – was identified from a blood sample taken from one of the first US patients who recovered from COVID-19 and developed in less than three months by Lilly scientists. It is designed to block viral attachment and entry into human cells, thus neutralising the virus.

Etesevimab – licensed from China’s Junshi Biosciences – is a recombinant fully human neutralising mAb that binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor.

Since the emergency use authorisation in February more than 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalisations and at least 14,000 deaths during the worst of the pandemic, says Lilly.

Lilly has performed ‘pseudovirus and authentic virus studies’ to confirm that the treatments retain activity against the dominant Delta variant of concern and is ’working quickly’ to understand its effect against the Omicron variant of concern.

The expanded authorisation is based on safety data from the phase 2/3 BLAZE-1 trial involving 125 paediatric patients with at least one risk factor for severe COVID-19 and efficacy data from adolescents and adults.

Article by
Hugh Gosling

6th December 2021

From: Regulatory



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