Connecticut Department Of Public Health Supports The FDA’s Decision To Limit Use Of Certain Monoclonal Antibodies To Treat COVID-19
FOR IMMEDIATE RELEASE: Jan. 27, 2022
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Connecticut Department Of Public Health Supports The FDA’s Decision
To Limit Use Of Certain Monoclonal Antibodies To Treat COVID-19
HARTFORD, Conn. — Connecticut Department of Public Health Commissioner Manisha Juthani, MD, said Thursday that DPH supports the US Food and Drug Administration’s revision of the authorizations for two monoclonal antibody treatments---Bamlanivimab and Etesevimab (administered together) and REGEN-COV (Casirivimab and Imdevimab).
The FDA revised its authorization for use of these treatments for patients who likely have been infected with or exposed to a COVID-19 variant that is susceptible to these treatments.
“Data reviewed by the FDA shows that these treatments are unlikely to be effective against the omicron variant,” Commissioner Juthani said. “These treatments are not authorized for use in the United States at this time.”
Commissioner Juthani added that monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as severe acute respiratory syndrome coronavirus 2 also known as SARS-CoV‑-‑2.
SARS-CoV‑-‑2 is the coronavirus that causes COVID-19 which can mutate over time, resulting in certain variants such as omicron.
“The omicron variant is estimated to account for more than 99 percent of the cases in the United States as of mid-January,” Commissioner Juthani said. “Fortunately, there are several other therapiesincluding Paxlovid, Sotrovimab, Remdesivir, and Molnupiravir that are expected to work against the Omicron variant. 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.”
DPH works with health care partners to target these medications to the most at-risk patients while allocations from the federal government are limited. These therapeutics are not currently at retail pharmacies. Availability and distribution is expected to increase in the coming months.
Commissioner Juthani said that monoclonal antibody treatments do not replace getting the COVID-19 vaccine which together with masking and testing are the best mitigation strategies against the virus.