FDA Authorizes Monoclonal Antibodies for Post-Exposure COVID-19 Prevention

The US Food and Drug Administration (FDA) has revised the previous emergency use authorization (EUA) granted to co-administered bamlanivimab and etesevimab to include an emergency use as post-exposure prevention for COVID-19 in adults and pediatric patients ≥12 years old who are at high risk of progression to severe COVID-19.

The indication, granted to Eli Lilly, expands the authorized utility of the combination monoclonal antibodies, which were initially granted an EUA for the treatment of mild-to-moderate COVID-19 in the same patient population who tested positive for SARS-CoV-2 and were deemed at risk of progression to severe disease.

The FDA stressed in announcing the newest authorized that combination bamlanivimab and etesevimab are not approved as a pre-exposure prophylaxis to prevent COVID-19 prior to SARS-CoV-2 exposure, and that the post-exposure authorization should not be deemed as a viable substitute for vaccination against COVID-19:

Patients eligible for post-exposure prophylaxis with bamlanivimab and etesevimab must meet the following requirements:

• Be deemed at high risk of progression to severe COVID-19, including hospitalization or death.
• Not be fully vaccinated or expected to mount an adequate immune response from SARs-CoV-2 vaccination, such as those with immunocompromising conditions or those taking immunosuppressant medication.
• Have been exposed to an individual infected with SARS-CoV-2 consistent with CDC criteria for “close contact” or be at high risk of exposure to an infected individual due to compromising settings such as long-term care facilities or prisons.

Bamlanivimab and etesevimab first received EUA for its initial indicated use of COVID-19 treatment in February 2019, on the basis of randomized, double-blinded, placebo-controlled trial data showing the single intravenous combination therapy significantly reduced hospitalization and death related to COVID-19 during 29 days of post-treatment follow-up versus placebo.