Authorizations

FDA Updates Recommendation Around AstraZeneca’s Evusheld

The FDA has revised its emergency use authorization for AstraZeneca’s Evusheld, a monoclonal antibody treatment for COVID-19. Due to emerging data, it has been observed that the original 150mg dose of each monoclonal antibody may be less likely to prevent infection than originally indicated. Thus, the FDA has authorized a double dose of each antibody for immunocompromised patients.

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FDA Authorizes Fourth Monoclonal Antibody Drug

Last Friday, the FDA authorized emergency use of Eli Lilly’s monoclonal antibody treatment, bebtelovimab, for treating mild-to-moderate COVID-19. Bebtelovimab has been shown to be highly effective against the Omicron variant, and is the fourth treatment made available for high-risk COVID patients. It has not been proven whether bebtelovimab can prevent severe disease, but trial data suggest that bebtelovimab may reduce viral replication when taken within 7 days upon onset of COVID-19 symptoms.

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FDA Expands Authorization Around Remdesivir to Treat COVID-19

On January 21, the FDA expanded the use of remdesivir to non-hospitalized adults and children who have mild-to-moderate COVID-19, who are at risk of severe disease. Previously, remdesivir was only available to hospitalized patients. This decision was based on a clinical trial including 562 participants with mild-to-moderate COVID-19, who had displayed symptoms within the previous 7 days and had at least one risk factor for severe disease.

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Immunocompromised persons may soon receive 4th dose

Last Friday, the CDC updated their vaccine guidance for immunocompromised persons. It is now recommended that persons 12+ who are immunocompromised receive a booster dose. “If you are eligible for an additional primary shot, you should get this done before you get a booster shot.”

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