FDA authorises Eli Lilly Covid therapy for under-12s

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Paediatric patients from birth to 12 years old can now be treated with an antibody drug for Covid-19. The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab to be administered together in high-risk paediatric patients for the treatment of mild to moderate Covid-19 as well as post-exposure prophylaxis.

“Our mission since the start of the pandemic has been to offer crucial support by developing therapeutic options that could prevent hospitalisation and death for as many people as possible,” said Daniel Skovronsky, Lilly’s Chief Scientific and Medical Officer and President of Lilly Research Laboratories. “With the FDA’s decision to allow use of bamlanivimab with etesevimab in children and infants, Lilly can now offer treatment and prevention options to high-risk individuals of any age.”

The expanded authorisation is based on safety and efficacy data of paediatric and infant patients in BLAZE-1, a Phase II/III clinical trial studying bamlanivimab and etesevimab administered together for the treatment of mild to moderate Covid-19 and who are at high risk for severe disease progression. The median time to complete symptom resolution as recorded in a trial specific daily symptom diary was seven days for subjects treated with bamlanivimab 700 mg and etesevimab 1,400 mg and five days for subjects treated with weight-based dosing of bamlanivimab and etesevimab. No paediatric subject died or required hospitalisation due to Covid-19.

Bamlanivimab and etesevimab, when administered together, retain neutralisation activity against the Delta variant. Lilly has performed pseudovirus and authentic virus studies to confirm that bamlanivimab with etesevimab retain neutralisation activity against the Delta variant. The company is working quickly to understand neutralisation activity on the Omicron variant.

To date, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab.

 

 

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