The U.S. Food and Drug Administration issued an emergency use authorization for Regeneron's antibody cocktail to treat Coronavirus in high-risk patients with mild to moderate disease.
Upon contracting the virus, President Donald Trump received the therapy, called REGEN-COV2, when he was hospitalized for days. The treatment has to be infused into the bloodstream and is meant to mimic an immune response to infection.
The FDA said in a news release that the cocktail reduced Covid-19-related hospitalizations and emergency room visits in some patients within 28 days of treatment.
Regeneron's chief executive officer, Dr. Leonard S. Schleifer, said in a statement that demand may initially exceed supply, "making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need."
"When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks," the FDA said.
Regeneron submitted its application for the authorization in October, shortly after Trump tested positive for the coronavirus and received the biotechnology company's antibody therapy.
"Regeneron now expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021," the company said in a news release Saturday.
Earlier on Friday, the drugmaker "Pfizer" and its German partner "Biontech" announced that they had submitted a request to the US Food and Drug Administration to approve the emergency use of the Covid-19 vaccine.
The companies expect the FDA to grant approval for emergency use by mid-December.
They said that they will start shipping the doses immediately, as Pfizer expected to have 50 million vaccine doses ready this year, a sufficient amount to protect 25 million people.
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