FDA scales back use of 2 monoclonal antibody treatments for COVID-19

key takeaways

  • The FDA recommends against the use of monoclonal antibodies from Eli Lilly and Regeneron to treat the Omicron COVID-19 variant because they are not very effective against this strain of the virus.
  • There are at least four other treatments Yes Effective against viruses.
  • Your best protection against COVID-19 is vaccination and booster doses.

After months of reports that two monoclonal antibody treatments against COVID-19 were ineffective against Omicron COVID-19 variants, the U.S. Food and Drug Administration (FDA) halted their use in the United States.

On January 24, the FDA revised the emergency use authorizations (EUAs) for bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) to limit their use to patients known to have been exposed to or infected with a COVID variant can be treated with these drugs. The drugs are produced by Eli Lilly and Regeneron, respectively.

Do Regeneron’s antibody cocktails contain stem cells?Knowledge about drugs

“Given the latest information and data available… FDA has revised its authorization to limit its use only to cases where patients may be infected or exposed to variants susceptible to these treatments,” said Patrizia Cavazzoni, FDA Drug Evaluation and the director of the research center, MD, said in a statement.

However, it is extremely unlikely that anyone in the US will have access to variants other than Omicron at this time. Therefore, these treatments should not be used at all.

“Because the data show that these treatments are unlikely to be effective against the omicron variant, which is circulating at a very high frequency in the United States, these treatments are not currently approved for use in any U.S. state, territory and jurisdiction,” Cavazzoni said. .

The Department of Health and Human Services, which is responsible for paying and distributing treatments, recently stopped shipping them to states, according to reports. Washington post.

have not seen you for a long time

Gregory Poland, MD, an infectious disease specialist at the Mayo Clinic, told VigorTip that the decision, and the time it took the FDA to change the EUA, underscores the difficulties the U.S. may face in treating variants of the coronavirus.

Some U.S. health systems, including several New York City hospitals, have already stopped using both treatments by the end of 2021. Early research published in December showed they were ineffective against Omicron.

How do you know which variant you are infected with?

While the FDA’s wording suggests that people with early COVID-19 variants, such as Delta, can be treated with these monoclonal antibodies, there’s really no way of knowing which variant you’re infected with, especially when a new wave begins.

“We’re guessing. We don’t have point-of-care testing to tell us what [variant] We are treating,” Poland said.

While laboratory-based genome sequencing tests can identify COVID-19 variants, these results are not intended for consumers. They are used for public health surveillance purposes only. In fact, the Centers for Medicare and Medicaid Services (CMS) states that a laboratory cannot return sequencing test results to a patient or provider if the laboratory is not accredited under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, while Many don’t.

Why a COVID-19 test won’t tell you which variant you might have

Which drugs are still available to treat COVID-19?

According to the National Institutes of Health’s COVID-19 Treatment Guidelines Group, the following treatments can be prescribed for people with mild to moderate COVID-19 who are at risk for severe viral infection, including hospitalization or death:

  • Sotrovimab: Monoclonal antibody IV infusion produced by GlaxoSmithKline.Authorized for use by people 12 and older
  • Paxlovid: An antiviral pill made by Pfizer.Authorized for use by people 12 and older
  • Molnupiravir: An antiviral pill made by Merck & Co.Authorized for use by persons 18 and older
  • Veklury (remdesivir): Antiviral intravenous fluids made my Gilead Sciences.Approved for use by persons 12 and older

How do Merck and Pfizer’s COVID Pills compare?

what does this mean to you

If your condition puts you at high risk for a severe case of COVID-19, there are still several effective treatment options available if you get sick. In addition, new drugs are being developed to target future strains of COVID-19.

The information in this article is current as of the date listed, which means that you may have updated information as you read this article. For the latest updates on COVID-19, visit our Coronavirus news page.