FDA grants Lilly’s COVID-19 antibody therapy EUA for paediatric use

pharmafile | December 6, 2021 | News story | Sales and Marketing  

Eli Lilly has been granted an expanded Emergency Use Authorisation (EUA) for its neutralising antibody treatment, based on the safety and efficacy data from the BLAZE-1 clinical trial in paediatric and infant patients of COVID-19. The combination treatment is already authorised for use in adults, and in patients aged 12 years and up.

Bamlanivimab and etesevimab are indicated to prevent and treat mild-to-moderate COVID-19 in paediatric patients and infants below 12 years of age, who are at increased risk of disease progression, including death and hospital admission.

The authorisation is based on the safety and efficacy results from the Phase II/III BLAZE-1 clinical trial of the therapy. The participants who received 700mg bamlanivimab and 1400mg etesevimab had a median complete symptom resolution time of seven days. The median duration to complete symptom resolution was five days in those who were given weight-based doses of the therapy. No cases of COVID-19-caused death or hospital admission were reported among paediatric patients in the trial.

The monoclonal antibodies hinder the attachment of the virus and its entry into human cells by targeting the SARS-CoV-2 spike protein. The authorisation follows news of the Omicron variant reaching the US.

In September 2021, the US Government additionally announced plans to purchase more doses of Eli Lilly’s antibody therapy.

“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,” shared Lilly Research Laboratories president, Daniel Skovronsky. “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.”

Ana Ovey

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