FDA authorizes COVID-19 antibody cocktail for younger children

The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns.

The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression.

The EUA previously covered children at least 12 years of age who weigh at least 40 kilograms.

The FDA will now allow the use of the antibody cocktail as post-exposure prophylaxis (PEP) to prevent COVID-19 in all pediatric patients with a high risk of progressing to severe COVID-19.

Bamlanivimab and etesevimab image courtesy of Lilly.

The expanded authorization is not intended to provide an alternative to vaccination, said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “Vaccines remain our best tool in the fight against the virus, an…

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HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington. 

The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351 (South African) variants. Those variants comprise more than 10% of COVID-19 infections in the eight states mentioned above. 

HHS still recommends Regeneron’s (NSDQ:REGN) REGEN-COV antibody cocktail in areas with significant spread of the P.1 and B.1.351 v…

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FDA nixes EUA for Lilly’s bamlanivimab

On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone.

Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants.

Bamlanivimab, however, won’t be disappearing as a COVID-19 treatment but will be paired with another monoclonal antibody known as etesevimab.

The combination of bamlanivimab and etesevimab won EUA status on Feb. 9 to treat mild to moderate COVID-19. The combination is more effective against emerging SARS-CoV-2 variants than either antibody alone.

FDA has indicated the combination of bamlanivimab and etesevimab for people 12 years of age and older who tested positive for SARS-CoV-2. To receive the drugs, patients must weigh at least 40 kg (88 pounds) and have a high risk of developing severe COVID-19 or hospitalization.

Some 400,…

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Lilly to prioritize selling antibody cocktail for COVID-19

Eli Lilly (NYSE:LLY) announced that it had amended purchase agreements with the U.S. government to prioritize using two monoclonal antibodies — bamlanivimab and etesevimab — in tandem.

In March, the U.S. government announced that it would stop using bamlanivimab alone, given its reduced efficacy against some SARS-CoV-2 variants.

But pairing anti-SARS-CoV-2 monoclonal antibodies together can offer more robust protection against variants. Using two of the monoclonal antibodies together is more protective than administering either alone.

The COVID-19 Treatment Guidelines Panel of the National Institutes of Health has recommended pairing Lilly’s bamlanivimab with etesevimab or Regeneron’s (NSDQ:REGN) cocktail combining casirivimab and imdevimab.

Bamlanivimab and etesevimab image courtesy of Eli Lilly.

Regeneron’s REGEN-COV drug is an antibody cocktail combining casirivimab and imdevima…

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Lilly’s bamlanivimab and etesevimab cut COVID-19 hospitalization and deaths in study

A recent Phase 3 trial found that bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19.

The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm. FDA granted emergency use authorization to the dosing regimen, which is also supported by the European Medicines Agency’s Committee for Medicinal Products for Human Use. A total of 258 patients in the cohort of the BLAZE-1 study received a placebo.

There were no deaths in the treatment arm but four deaths in the placebo arm. All of the deaths were considered related to COVID-19.

The BLAZE-1 trial has been ongoing for several months, giving Lilly the ability some indication that its monoclonal antibodies are effective against a range of SARS-CoV-2 varia…

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