WASHINGTON • •The US Food and Drug Administration (FDA) has granted emergency authorisation for the experimental antibody treatment given to President Donald Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the United States continue to rise. "Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system".
The White House cast the decision as a victory for Trump's efforts "to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans", according to a statement from spokesman Michael Bars. This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors, say Regeneron.
An emergency use of authorizations is different than an FDA approval.
The human immune system naturally develops infection-fighting proteins called antibodies - but because not everyone mounts an adequate response, companies like Regeneron and Lilly have manufactured lab-made solutions. They bind to the coronavirus and prevent it from invading cells.
Use is allowed for adults and children 12 and over who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.
For high-risk patients, hospitalizations and emergency room visits occurred in 3% of patients that received the treatment compared to 9% in placebo-treated patients.
Regeneron has said it will have enough of the drug for only about 80,000 people by the end of the month, enough for 200,000 patients by the first week of January, and 300,000 by the end of January.
These will be available to U.S. patients at no out-of-pocket cost under the terms of a USA government program.
The recommended dose is 1,200 milligrams of each of the two antibodies, for a total of 2,400 milligrams, in a single infusion.
In normal times the FDA requires "substantial evidence" to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies.
The White House celebrated the "promising results", and noted that the administration has spent close to half a billion dollars to support large-scale manufacturing of Regeneron's antibody treatment for delivery to USA hospitals.
So-called monoclonal antibodies are a relatively new class of drug seen as highly promising.
Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after an EUA. Regeneron's product will now be available to boost the supply, and the company estimates that 300,000 doses will be given to patients at no cost, though together there still won't be almost enough to serve all the people who could qualify for them. "In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche".