FDA asks to no longer use Regeneron and Eli Lilly antibody drugs against COVID-19

Antibody medications for COVID-19 of the companies Regeneron Y Eli Lilly should no longer be used because they are unlikely to have any effect against the omicron variant of the coronavirus, which currently accounts for the vast majority of infections in the United States, the Food and Drug Administration (FDA for its initials in English).

He said he would revoke emergency use authorization for both drugs, which were purchased by the federal government and administered to millions of Americans with COVID-19. If the drugs prove effective in combating new variants, the agency said it could reauthorize their use.

The move was expected, as both pharmaceutical companies had said that the aforementioned drugs are less capable of combating omicron due to their mutations. Either way, the federal move could draw criticism from some Republican governors who have continued to promote the drugs despite advice from health experts.

Omicron resistance to the two main monoclonal antibody drugs has affected treatment plans for COVID-19 in recent weeks.

Doctors are counting on alternative therapies to combat early-stage COVID-19 cases, including the arrival of two new antiviral pills from Pfizer and Merck, but supplies of both drugs are low. The same case applies to an antibody drug from the GlaxoSmithKline company that remains effective against the disease.

The drugs are laboratory-made versions of the antibodies that block the virus. Its goal is to prevent severe illness and death by providing concentrated doses of one or two antibodies early in the infection. Then-President Donald Trump received a combination of antibodies from Regeneron after testing positive for coronavirus in 2020.

The FDA noted in its decision that omicron is responsible for more than 99% of infections in the United States, making it “highly unlikely” that the antibodies in these drugs will help people seeking treatment now. The agency said restricting its use would also eliminate the drug’s unnecessary side effects, including allergic reactions.

The US government temporarily suspended distribution of both drugs in late December, as omicron spread across the country to become the dominant variant. However, authorities resumed distribution after complaints from Republican governors, including Florida’s Ron DeSantis, who said the drugs were still helping some omicron-infected patients.