Regeneron Antibody Treatment Granted Emergency Authorization By FDA
Scientist developing antibody medicines in Regeneron’s lab.

The US Food and Drug Administration (FDA) authorised an experimental antibody cocktail produced by Regeneron for emergency use on Saturday. The treatment, consisting of the two antibodies casirivimab and imdevimab, will be limited to patients aged 12 and over with positive SARS-CoV2 test results and at risk of developing severe COVID-19. 

Clinical trial results showed that the cocktail reduced hospitalisations and emergency room visits within 28 days after treatment. The greatest benefit is achieved early in the course of the disease. The FDA warned of the potential for negative clinical outcomes when administered to hospitalised patients requiring oxygen or mechanical ventilation. 

“Authorising these monoclonal antibody therapies may help outpatients avoid hospitalisation and alleviate the burden on our health care system,” said Stephen Hahn, FDA Commissioner. 

The antibody cocktail gained publicity after it was given to President Trump when he was diagnosed with COVID-19 in early October. The two antibody components function by targeting the spike protein of SARS-CoV2, blocking the attachment and entry of the virus into human cells. 

“The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralise the virus,” said George Yancopoulos, CEO of Regeneron, in a press release

Regeneron has said it expects to have enough doses for 80,000 patients by the end of November and 300,000 patients by the end of January 2021. The biotech company signed a supply agreement with Operation Warp Speed – a US government program to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics – for the 300,000 treatment doses. 

The evaluation of the safety and efficacy of the treatment cocktail will continue in Phase 2 and 3 clinical trials. FDA approval may follow a rigorous evaluation of the scientific evidence from the clinical research and safety monitoring. 

Debate Over Access to New Monoclonal Antibody Treatments Heating Up

So far Regeneron has the capacity to produce about 300,000 doses of its antibodies casirivimab and imdevimab, most of which will go into the US market. Meanwhile, however, low- and middle income countries are anxiously eyeing these new developments to see how they might access cutting-edge technologies.

WHO’s Act Accelerator initiative has set into place the procurement framework to purchase  monoclonal antibodies through its therapeutics arm, if those are approved. But so far it’s not clear who would produce these for the wider global market. Nor is it clear if Regeneron and others will issue licenses for their products to others – or if a standoff over access may wind up in the ballpark of the World Trade Organization, which is discussing an “IP waiver” on needed health products for the duration of the pandemic.

Image Credits: Regeneron.

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