St. Louis, Missouri 2020-11-21 21:49:00 –
(CNN)-The US Food and Drug Administration issued an emergency permit for Regeneron’s antibody cocktail on Saturday to treat Covid-19 in high-risk patients with mild to moderate illness.
President Donald Trump received a treatment called REGEN-COV2 when he was hospitalized for the coronavirus. Treatment requires injection into the bloodstream and is intended to mimic the immune response to infection.
The FDA said in a news release that cocktails reduced some patients’ Covid-19-related hospitalizations and visits to emergency rooms within 28 days of treatment.
Leonard S, CEO of Regeneron. In a statement, Dr. Schleifer said demand could initially exceed supply, “ensuring that the federal and state governments distribute REGEN-COV2 fairly and equitably to patients in greatest need. Is even more important.
The Emergency License (EUA) is a lower regulatory standard than the full FDA approval. The EUA permits the use of the product under certain circumstances before all evidence has been approved.
“When used to treat COVID-19 in an approved population, the known potential benefits of these antibodies outweigh the known potential risks,” the FDA said.
Regeneron filed an application for approval in October, shortly after Trump tested positive for the coronavirus and received antibody therapy from a biotechnology company.
“Regeneron is currently expected to provide REGEN-COV2 treatment doses to approximately 80,000 patients by the end of November, approximately 200,000 by the first week of January, and a total of approximately 300,000 patients by the end of January 2021. “We are,” the company said. Saturday news release.
Treatment is for use early in the infection
Unlike some other drugs used for Covid-19, antibody cocktails are intended to be given early in the infection, before the patient is hospitalized or needs oxygen therapy. .. According to the FDA, the drug should be given as soon as possible after a positive virus test.
FDA approval is limited to high-risk patients, such as those aged 65 and over or with a BMI of 35 and above. Patients with other conditions such as diabetes, cardiovascular disease, and chronic kidney disease are also eligible for this drug. ..
Authorization applies only to patients 12 years and older. Cocktails are not approved for use in patients who are hospitalized with Covid-19 or who require oxygen therapy for Covid-19.
Regeneron’s cocktail is a combination of two laboratory-produced monoclonal antibodies, cashiribimab and imdebimab.
Antibodies target spike proteins that the virus uses to puncture healthy cells. With the two antibodies, it is expected to trap and shut down virus replication.
“The FDA continues to work to promote national public health during this unprecedented pandemic. Approving these monoclonal antibody therapies helps outpatients avoid hospitalization and our medical care. It may help reduce the burden on the system, “FDA Commissioner Dr. Stephen Hahn said in a statement.
Regeneron is not the only company working on antibody therapy for coronavirus. According to BIO, an association representing major biotechnology companies, Covid-19 under investigation has over 70 different antibody therapies.
Earlier this month, the FDA issued an emergency license for another antibody treatment from Eli Lilly, a drug company with similar conditions.
Shelby Lin Erdman of CNN contributed to this report.
FDA authorizes emergency use of the antibody cocktail given to Trump to treat Covid-19 | News Headlines Source link FDA authorizes emergency use of the antibody cocktail given to Trump to treat Covid-19 | News Headlines