Regeneron has received US emergency approval for its antibody treatment, which was hailed by President Donald Trump as a cure for his Covid-19.
The US Food and Drug Administration issued an emergency use authorisation for the antibody cocktail for the treatment of mild-to-moderate Covid-19 patients at high risk of developing severe symptoms, such as people older than 65 and those suffering from chronic conditions.
The emergency approval is based on a clinical trial that found the drugs — a combination of casirivimab and imdevimab — reduced hospitalisation or visits to the emergency room by high-risk patients. It was given the green light after Eli Lilly received an EUA for a similar antibody treatment.
Stephen Hahn, the FDA commissioner, said the regulator was using “every possible pathway” to get treatments to patients, while continuing to monitor their safety and efficacy.
“Authorising these monoclonal antibody therapies may help outpatients avoid hospitalisation and alleviate the burden on our healthcare system,” he said.
Regeneron’s antibody cocktail was one of several medicines given to President Trump when he was suffering from Covid-19. In a video, he was effusive about the drug, calling it a “miracle”.
But experts are clear it is not a cure — and does not work for everybody. The EUA does not cover patients already in hospital and the FDA warned the antibody treatments may be harmful for those requiring high flow oxygen or who are on a ventilator. Regeneron’s trial with such seriously ill patients was halted last month.
The antibody treatments work best earlier in the course of the disease when they can boost a body’s immune system. But as they are delivered by an infusion, health systems are still working out exactly how to give them to outpatients and, with supplies tight, who to prioritise.
Leonard Schleifer, Regeneron’s chief executive, said the EUA was an “important step” in the fight against Covid-19, giving patients in the initial stages of the disease a “promising therapy”.
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Regeneron expects to have 80,000 doses ready by the end of November and 300,000 by the end of January. It will expand production as part of its collaboration with Roche, the pharmaceutical company, in the first quarter of 2021.
The US government has already signed a deal to provide 300,000 free doses to patients. Dr Schleifer called on the federal and state governments to ensure it was “distributed fairly and equitably to the patients most in need”.