The U.S. Food and Drug Administration has expanded the emergency use authorization of Regeneron Pharmaceuticals Inc’s COVID-19 antibody cocktail, enabling its use as a preventive treatment for the illness in certain people.
Article continues below
>
The FDA revised the Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) to add an authorization of REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death.
REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus only after exposure to the virus. REGEN-COV should only be used as post-exposure prophylaxis for specific patient populations.
Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19.
FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible. Learn more about FDA’s COVID-19 vaccination efforts.
On July 28, the FDA revised the EUA for baricitinib (sold under the brand name Olumiant) now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Under the revised EUA, baricitinib is no longer required to be administered with remdesivir (Veklury). Baricitinib is not FDA-approved as a treatment for COVID-19.
On Wednesday, the FDA authorized an extension for the shelf life of the refrigerated Janssen (Johnson & Johnson) COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for six months.
This extension from four and a half months to six months was granted following a thorough review of data submitted by Janssen and applies to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions.
The expiration dates for vaccines that are authorized under an EUA may be extended based on data submitted by the manufacturers, and in accordance with FDA’s authorization.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter to the operator of www.rxmedkart.com for selling unapproved drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. ■