Lilly drug becomes first COVID antibody cleared for use in young children

Monday, December 6, 2021

Source: Biopharma Dive

Dive Brief:

  • The Food and Drug Administration has granted emergency authorization to Eli Lilly's COVID-19 antibody combination in children as young as newborns, announcing Friday that doctors can begin prescribing the drugs for both treatment and post-exposure prevention in those at high risk of severe disease.
  • Lilly's is the first antibody-based COVID treatment to gain authorization for children under 12. Lilly's drugs, called bamlanivimab and etesevimab, had won clearance for children 12 and older weighing at least 40 kilograms, which is the limit for antibody treatments developed by Regeneron and partners GlaxoSmithKline and Vir Biotechnology.
  • The authorization comes as hospitals and clinics in the U.S. continue to grapple with infections caused by the delta variant, which caused an increase in pediatric cases. Public health authorities, meanwhile, expect the new omicron variant to become the predominant strain in coming months, which may require more treatment options. Antiviral pills from Merck & Co. and Pfizer are also expected to gain authorization in coming weeks.

Dive Insight:

When bamlanivimab gained initial authorization 13 months ago, it was the first drug specifically designed to arrest infections of the SARS-CoV-2 virus that causes COVID-19. Up until that point, drugs used to treat severe cases had been repurposed, such as dexamethasone or Gilead's Veklury, which was originally developed for hepatitis and Ebola.

Bamlanivimab and etesevimab are synthetic antibodies, binding to the coronavirus' signature spike protein and preventing the virus from entering cells and replicating further. Bamlanivimab's authorization as a single agent was closely followed by one for a dual-antibody combination from Regeneron, and then months later Vir and GSK won clearance for a single antibody treatment.

But as coronavirus variants emerged, the U.S. government withdrew bamlanivimab as a single agent, and Lilly added etesevimab to the combination to improve effectiveness. Dual-antibody combinations are thought to be more resistant to viral mutations as the individual drugs bind to separate places on the virus.

To gain authorization in children, Lilly submitted data from use of bamlanivimab and etestevimab from pediatric patients in a study called BLAZE-1. The company found weight-based doses led to symptom resolution in five days, compared with seven days for those given the adult dose.

As injectable drugs that require patients to visit healthcare facilities, antibodies haven't been used as widely as they could be or administered early enough in the course of disease to make a difference. Antiviral pills from Merck and Pfizer, however, may change how symptomatic cases are treated as patients could potentially treat themselves at home over just a few days.

Merck's pill, called molnupiravir, won a close vote from an FDA expert panel last week and is expected to gain emergency authorization. However, children may not be allowed to use that pill because of the potential to cause damage to bones.

Pfizer, meanwhile, is expected to ask the FDA for emergency authorization in coming weeks.

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