Why is the FDA restricting 2 monoclonal antibody drugs to treat COVID? What to know

Two monoclonal antibody therapies used to treat COVID-19 are now restricted for use throughout the U.S. and its territories by the Food and Drug Administration after the agency revised its authorizations for the two drugs.

The reason is the infectious omicron variant, which makes up an estimated 99.5% of positive coronavirus cases across the county as of Jan. 15, according to data from the Centers for Disease Control and Prevention. Monoclonal antibodies, which are made in a laboratory and act similar to a person’s natural antibodies, make it difficult for the coronavirus to replicate.

Here’s what you should know:

The FDA’s update

Regeneron’s monoclonal antibody treatment, REGEN-COV (casirivimab and imdevimab), and Eli Lilly’s monoclonal antibody treatment, bamlanivimab and etesevimab, are “highly unlikely to be active against the omicron variant” according to recent data, said Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, in a Jan. 24 news release.

Now, their use will be allowed only when a patient “is likely to have been infected with or exposed to a variant that is susceptible to these treatments,” Cavazzoni said.

“It’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time.”

Cavazzoni said this will prevent patients from experiencing certain side effects from these drugs, including potential serious allergic reactions, “that are not expected” to help treat those who’ve been infected with omicron.

This comes after the National Institutes of Health’s COVID-19 Treatment Guidelines panel warned on Jan. 19 that the two treatments might not be effective against the omicron variant.

Despite the restriction, “there are several other therapies” for treating omicron, Cavazzoni said, including the monoclonal antibody treatment sotrovimab.

Sotrovimab is the “only available” monoclonal antibody treatment that shows effectiveness against omicron, according to the NIH.

Cavazzoni emphasized that though it’s important to have multiple options for COVID-19 treatment, the FDA-authorized treatments aren’t a “substitute” for vaccination and booster doses as recommended.

What are monoclonal antibodies?

Monoclonal antibodies are created in a laboratory, and they imitate how a person’s natural antibodies combat viruses and infections, according to the U.S. Department of Health and Human Services. With treatment, they are administered through infusion, and they can stop the coronavirus from infecting cells.

The agency says monoclonal antibodies can be used for those who are at risk of developing severe symptoms of COVID-19 and for those who recently tested positive or have been exposed to someone who’s positive.

This treatment is different from vaccination because a COVID-19 vaccine “triggers your body’s natural immune response” but “this can take weeks to develop enough antibodies against a virus,” according to HHS.

Reactions to the FDA’s decision

The FDA’s decision unleashed reactions — particularly in Florida where all of the state’s monoclonal antibody sites have shut down as a result, according to the Florida Department of Health, which called the agency’s move “abrupt.”

“Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments,” Florida Gov. Ron DeSantis wrote in a Jan. 25 tweet.

DeSantis called for the Biden administration to “reverse” its decision on Regeneron and Eli Lilly’s treatment options in a Jan. 24 news release.

Since Florida shut down its monoclonal antibody sites, more than 2,000 appointments in Florida were canceled for Jan. 25, DeSantis said.

Ian Sams, a HHS spokesperson, fired back at DeSantis’ Twitter statement, saying Regeneron and Eli Lilly’s products “don’t work” against omicron and that “the drugmakers themselves say so,” in a Jan. 25 tweet.

Eli Lilly said it agrees with the FDA’s decision that it’s “not medically appropriate, at this time, to treat patients with mild to moderate COVID-19” with the company’s monoclonal antibody drug, according to a statement issued to a CBS 12 reporter shared to Twitter.

Dr. Christian Ramers, an infectious disease specialist at Family Health Centers of San Diego, said the use of the two now-restricted products are “not justified at this point unless there’s some other underlying secondary gain, political pressure, or perhaps the providers are truly not in touch with the reality of the variant proportions,” according to Kaiser Health News.

Other treatment options

In addition to the monoclonal antibody treatment sotrovimab, Cavazzoni pointed to Paxlovid, Veklury (remdesivir) and molnupiravir as other therapies “expected to work against the omicron.”

These “are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death,” Cavazzoni added.

Paxlovid, developed by Pfizer, and molnupiravir, developed by Merck, are two COVID-19 oral pills recently authorized by the FDA.

Meanwhile, Veklury — intravenous remdesivir that requires infusion for three days — “is expected to be active” against omicron, according to the NIH.

The full list of COVID-19 treatments authorized by the FDA can be accessed here.

“Healthcare providers should consult the NIH panel’s COVID-19 treatment guidelines and assess whether these treatments are right for their patients,” Cavazzoni said.

“The FDA is committed to continuing to review emerging data on all COVID-19 therapies related to the potential impact of variants and revise the authorizations further as appropriate to ensure healthcare providers have an effective arsenal of treatments for patients.”

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