FDA Reverses Authorization of Monoclonal Antibodies to Treat COVID-19

Yesterday, the US Food and Drug Administration (FDA) revised their previous authorization of monoclonal antibody treatments, saying the therapy is unlikely to prove effective against the Omicron variant.

The decision comes in light of Centers for Disease Control and Prevention (CDC) data that suggests the Omicron variant is responsible for over 99% of COVID-19 cases in the US. Because it is highly unlikely a patient will be infected with any variant other than Omicron, the FDA said that no monoclonal antibody treatment is to be administered at this time.

The FDA added that taking monoclonal antibody therapy off the table avoids exposing patients to side effects, such as injection site reactions or allergic reactions.

This update affects 2 monoclonal antibody treatments (bamlanivimab and etesevimab; casirivimab and imdevimab [REGEN-COV]) that had previously been FDA approved to treat COVID-19 infection.

Monoclonal antibodies are made in a laboratory to mimic the antibodies produced by the body’s immune system. Monoclonal antibodies are introduced to the body through intravenous (IV) injection look for and attach to the SARS-CoV-2 spike protein, blocking the virus’s ability to enter cells and slowing down the infection.

Monoclonal antibody treatment has been shown to reduce the risk of COVID-19 hospitalization, as well as decrease the amount of virus in a person’s blood.

The decision to rescind approval of monoclonal antibody treatment for the Omicron variant has been met with some resistance, most notably from Florida Governor Ron DeSantis.

DeSantis called upon the Biden Administration to reverse the decision, saying, “Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law…This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives."

DeSantis argued that even if less effective against Omicron, monoclonal antibody treatment is “better than nothing.”

In their reversal of the prior approval, the FDA cited several other treatments that are expected to work against Omicron, including Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir.

In a statement from Patrizia Cavazzoni, MD, the director of the Center for Drug Evaluation and Research, the FDA emphasized, “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. Data has clearly demonstrated that the available, safe and effective vaccines can lower your risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death.”