While the US presidential election drew a significant amount of attention away from the global battle against COVID-19, the US Food and Drug Administration (FDA) kept busy offering advice, taking action and considering potential therapies, vaccines, tests and other solutions.
As reported in BioPharma-Reporter, the FDA granted an emergency use authorization (EUA) to Eli Lilly’s monoclonal antibody therapy, bamlanivimab (LY-CoV555). The neutralizing IgG1 monoclonal antibody is intended to prevent the viral attachment and block it from entering human cells, thereby neutralizing the virus and preventing COVID-19 spread.
The US government plans to allocate 300,000 doses of the antibody to high-risk patients, with no out-of-pocket charge for the treatment. Lilly recommends LY-CoV555 be given as soon as possible after a patient receives a positive COVID-19 test and within 10 days of symptoms.
The agency authorized the first serology test that detects neutralizing antibodies from recent or prior COVID-19 infections. Th cPass SARS-CoV-2 Neutralization Antibody Detection Kit, received an EUA from the FDA.
While the FDA has issued EUAs to more than 50 serology tests, tests approved before this could only detect the presence of binding antibodies. “The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
No consumer products have been approved by the FDA for prevention, diagnosis, treatment or cure of the virus. However, unscrupulous companies continue to promote and sell products making such claims to the public—here are the latest to receive warnings from the federal government:
- Everything Aquatic and Mr Frags LLC, companies that distribute chloroquine phosphate products to treat disease in aquarium fish, received letters advising them against offering their products as treatment for humans.
- The FDA and Federal Trade Commission jointly issued warning letters to three companies offering fraudulent COVID-19 treatments: Peterson Research Laboratories (dba Covercology), Predator Nutrition, and Beepothecary.
- Spartan Enterprises Inc. (dba Watershed Wellness Center) was cited for selling Dissolve BioActive Silicate and other silver-containing products purported to treat COVID-19.
- NovaBay Pharmaceuticals received a warning for selling Antimicrobial Avenova Direct 20 ml Spray Solution and Antimicrobial All-Natural Facial Spray, with false COVID-19 claims.
Additionally, a US District Court granted a motion for default judgment and permanent injunction against Xephyr LLC (dba N-Ergetics), Derrill Jinks Fussell, and Linda Sue Fussell for violating federal law by distributing their colloidal silver products as preventions or treatments for COVID-19. The defendants had been warned in March to stop selling such products, and they failed to cease their violations.