FDA expands authorisation of two monoclonal antibodies for treatment and post-exposure prevention of COVID-19 to paediatric patients

The United States Food and Drug Administration (FDA) has revised the Emergency Use Authorisation (EUA) of Bamlanivimab and Etesevimab (previously authorised for paediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorise Bamlanivimab and Etesivimab administered together for the treatment of mild-to-moderate COVID-19 in all younger paediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalisation or death. This revision also authorises Bamlanivimab and Etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all paediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalisation or death, the US regulator said in a statement, recently.

“Now, all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention. 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,” said Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research, FDA.

Cavazzoni added that while the authorisation includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination. “Vaccines remain our best tool in the fight against the virus and there is a COVID-19 vaccine authorised for children five years of age and above,” she emphasised.

According to the statement, Bamlanivimab and Etesevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. The two bind to different, but overlapping sites on the spike protein of the virus.

It further said that in February, the FDA originally authorised the two antibodies administered together to treat mild-to-moderate COVID-19 in adults and paediatric patients (12 years of age or older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high-risk for progressing to severe COVID-19 and/or hospitalisation. In September, the agency authorised its use for post-exposure prevention of COVID-19 in certain adults and paediatric individuals (12 years of age and older weighing at least 40 kg) who are at high-risk for progression to severe COVID-19, including hospitalisation or death.

To support today’s action, Bamlanivimab and Etesevimab, administered together, were studied in a clinical trial of 125 paediatric patients (14 adolescent patients received placebo), all with at least one risk factor for severe COVID-19, to evaluate the safety and pharmacokinetics of treatment in paediatric patients. Patients weighing less than 40 kg (88 pounds) received doses of Bamlanivimab and Etesevimab adjusted for their body weight, to achieve comparable exposures to adults and adolescents receiving the authorised dose. Given the similar course of COVID-19 disease, the authorisation of Bamlanivimab and Etesevimab in younger pediatric patients, including neonates, is supported by safety and efficacy data in adolescents and adults, together with additional pharmacokinetic and safety data from the clinical trial in paediatric patients, mentioned the statement.

It also shed light on serious adverse events, including hypersensitivity, anaphylaxis and infusion-related reactions, that have been observed with Bamlanivimab with and without coadministration of Etesevimab. Possible side effects of Bamlanivimab and Etesevimab administered together include nausea, dizziness, pruritus and rash.

Under the EUA, fact sheets that provide important information about the emergency use of Bamlanivimab and Etesevimab, to be administered together, must be made available to healthcare providers and to patients, parents and caregivers. These fact sheets include dosing instructions, potential side effects and drug interactions. The EUA was issued to Eli Lilly and Co, concluded the statement.