Update on FDA COVID-19 activity, advice, and action

08-Jun-2021 - Last updated on 08-Jun-2021 at 15:40 GMT

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Related tags Fda COVID-19 Coronavirus Regulation Testing

The US agency’s latest actions and advice against the virus include information on test recalls, , approval and reauthorization of treatments, and more.

According to the most recent White House press briefing on vaccine progress in the US, approximately 52% of adults are fully vaccinated. While the country makes progress in inoculating the populace, the US Food and Drug Administration (FDA) maintains its position as a resource for information on the COVID-19 virus, and watchdog over the development of treatments, tests, and more.

COVID-19 test recalls

The agency issued a safety communication warning against the continued use of two separate tests:

Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit
Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography)

The FDA reportedly holds serious concerns about the performance of the two tests, believing there might be a high risk of false results.

Neither of the two tests (sold at pharmacies and direct-to-consumer for home use) has been authorized, cleared, or approved by the FDA. This announcement is categorized as a Class because the FDA has serious concerns about the performance of the tests and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA. The FDA has identified this issue as a class I recall, the most serious classification of recall.

NDA approved for inhalable therapy

The agency approved an abbreviated new drug application (NDA) for albuterol sulfate inhalation aerosol 90 mcg (base)/actuation. The therapy typically is used to treat or prevent bronchospasm (narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease (such as asthma) and for the prevention of exercise-induced bronchospasm in patients four years of age and older.

The most common side effects associated with albuterol sulfate inhalation aerosol are headache, dizziness, tachycardia (rapid heart rate), chest pain, pharyngitis (sore throat), and rhinitis (runny nose).

COVID-19 drug update

The FDA reissued the Letter of Authorization for REGEN-COV (Casirivimab and Imdevimab) treatment for COVID-19 to authorize the following:

Dosage change from 1200 mg of casirivimab,and 1200 mg of imdevimab to 600 mg of casirivimab and 600 mg of imdevimab
A new coformulation presentation that contains 600 mg of casirivimab and 600 mg of imdevimab in a single vial
Addition of subcutaneous injection as an alternative route of administration, when intravenous infusion is not feasible and would lead to delay in treatment.

GSK antibody approved

The agency issued an emergency use authorization (EUA) to GlaxoSmithKline for the investigational monoclonal antibody therapy sotrovimab for treating mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The drug has not been authorized for patients hospitalized due to COVID-19 or requiring oxygen therapy due to COVID-19. Further, the treatment reportedly not shown benefit in patients hospitalized due to COVID-19, and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation.

Unauthorized treatments and cures

Companies looking to profit off the pandemic continue to manufacture, distribute and sell products purporting to treat or cure COVID-19. At the same time, the FDA keeps an eye out for such unauthorized products, issuing warning letters to manufacturers.

The agency issued a warning letter jointly with the Federal Trade Commission (FTC) to Oclo Nanotechnology for selling unapproved chlorine dioxide products with unproven COVID-19 claims. Drinking products containing chlorine dioxide product can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.
BGP LLC received a warning letter from the FDA and FTC for selling unapproved products purporting to treat COVID-19.