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FDA poised to stop monoclonal antibody treatments that are ineffective against the Omicron COVID-19 variant

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Outside the FDA offices in Atlanta on Thursday, Dec. 10, 2020 in Atlanta, GA.
Outside the FDA offices in Atlanta on Thursday, Dec. 10, 2020 in Atlanta, GA.Jason Armond / Los Angeles Times via Getty Images
  • The FDA is set to stop monoclonal antibody treatments, the agency announced Monday.

  • The treatments are thought to be a ineffective remedy against the Omicron COVID-19 variant.

  • Distribution of drugs made by pharmaceutical companies Eli Lilly and Regeneron will be paused.

The US Food and Drug Administration is set to stop monoclonal antibody treatments that are thought to be an ineffective remedy against the Omicron COVID-19 variant, the agency announced Monday.

The treatments — made by pharmaceutical companies Eli Lilly and Regeneron — will be restricted, the FDA said in a press release, citing data that show the treatments are unlikely to be effective against the highly-transmissible Omicron variant.

"In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions," the agency said.

The FDA revised authorizations for both bamlanivimab and etesevimab, which are administered together, and REGEN-COV, comprising of casirivimab and imdevimab. The laboratory-made proteins are meant to mimic the immune system's response to harmful viruses, but as COVID-19 has mutated over time, the two treatments are no longer effective, according to the agency.

The federal government is expected to pause distribution of the treatments, following the FDA's announcement.

Antibody treatments from GlaxoSmithKline and Vir Biotechnology, however, appear to be effective and will remain in use, according to a Bloomberg report.

The move comes after an independent panel of national experts recently recommended against the use of the treatment, the FDA said Monday.

The agency noted that there are still multiple other therapies, including Paxlovid and Veklury (remdesivir), that are still believed to effectively fight against the Omicron variant and are authorized to treat some COVID-19 patients.

"While it's critical that we have ways to treat those who contract COVID-19, the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended," the press release said.

The FDA declined to comment further on the matter.

According to the latest Centers for Disease Control and Prevention data, the US is averaging over 716,000 daily new COVID-19 cases over the last week — a figure slightly lower than the average of 800,000 new cases a day in mid-January.

The agency estimates that the highly transmissible Omicron variant is responsible for over 99% of all COVID-19 cases in the country, according to the latest figures from January 15.

Read the original article on Business Insider

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