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FDA Clears Covid-19 Dual-Antibody Therapy

SARS-Cov-2 viruses

Scanning electron microscope image showing SARS-CoV-2 viruses, in yellow. (NIAID, NIH)

10 Feb. 2021. The Food and Drug Administration granted an emergency authorization for a combination of two synthetic antibodies to treat non-hospitalized Covid-19 infections. The cocktail of two monoclonal antibodies, bamlanivimab and etesevimab, is made by Eli Lilly and Co. in Indianapolis for people with Covid-19 infections showing mild to moderate symptoms, but considered at high risk for severe symptoms of the disease.

Bamlanivimab and etesevimab are synthetic antibody proteins, similar to natural immunoglobulin-G  antibodies in the immune system. The two antibodies are designed to connect to separate, but overlapping receptor binding sites of a protein on the surface of the SARS-CoV-2 virus spike that penetrates host cells and begins the infection process. That binding action neutralizes the virus’s ability to infect cells.

FDA authorized the dual-antibody cocktail for people with mild to moderate infections, but not hospitalized with the disease. The emergency authorization covers adult Covid-19 patients, and as young as age 12 weighing more than 40 kilograms (88 lbs.). The two antibodies are given as an intravenous infusion, with 700 milligrams of bamlanivimab and 1,400 milligrams of etesevimab. Eli Lilly says the infusion time for bamlanivimab alone is now 16 minutes, and 21 minutes for bamlanivimab and etesevimab, down from the original 60 minutes.

FDA’s authorization is based on results from a mid-stage clinical trial testing bamlanivimab alone and with etesevimab against a placebo, among 3,300 participants. Hospitalizations and deaths among recipients of the two antibodies were 70 percent lower than placebo recipients. Deaths for any reason were also lower among bamlanivimab and etesevimab recipients than those receiving the placebo. Serious and unexpected adverse side effects include hypersensitivity, anaphylaxis, and infusion-related reactions. Other adverse reactions observed were nausea, dizziness, itching, and rash.

Different treatments needed for new virus variants

Daniel Skovronsky, Eli Lilly’s chief scientist, says in a company statement that treatments with multiple ways of acting are needed to counteract emerging variations in the SARS-CoV-2 virus. He notes, “with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world.”

Bamlanivimab was initially developed by biotechnology company AbCellera Biologics in Vancouver as a synthetic antibody designed to neutralize the SARS-CoV-2 spike protein, which Eli Lilly licensed by in March 2020. In November 2020, FDA authorized bamlanivimab for emergency use to treat out-patients testing positive for the SARS-CoV-2 virus with mild to moderate Covid-19 symptoms, but at high risk of more serious infections.

As reported last month by Science & Enterprise, results from a clinical trial show long-term care residents and staff receiving bamlanivimab have a lower risk of getting symptomatic Covid-19 infections. In addition, Eli Lilly is testing bamlanivimab in combination with an antibody made by Vir Biotechnology and GlaxoSmithKline, as well as with etesevimab, against a placebo. The companies also cited emerging SARS-CoV-2 mutations as a reason to find therapies with different ways of treating Covid-19 infections and symptoms.

An emergency use authorization allows for short-term use of unapproved pharmaceuticals and medical devices, including diagnostics, in medical emergencies, such as the current Covid-19 pandemic. Drugs and devices given emergency authorizations still must file for full-scale approvals by FDA.

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