FDA Authorizes Monoclonal Antibodies for Post-Exposure COVID-19 Prevention
The emergency authorization granted to combination bamlanivimab and etesevimab is the second indicated in this last year.
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.