COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Revokes EUA for a Monoclonal Antibody Treatment, Citing Its Ineffectiveness in Treating SARS-CoV-2 Variants

FDA maze of regulations
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EUA revocation indicates that SARS-CoV-2 mutations are beginning to impact COVID-19 treatment efficacies

The US Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) for the monoclonal antibody drug bamlanivimab when it is administered alone. Bamlanivimab’s EUA previously allowed it to be used for the treatment of mild to moderate COVID-19 in adults and some pediatrics.

The FDA specifically cited the emergence of resistant SARS-CoV-2 variants that bamlanivimab is not effective in treating.

While the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, MD, Director of the FDAs Center for Drug Evaluation and Research. We urge the American public to seek out these therapies when needed while we continue to use the best data available to provide patients with safe and effective treatments during this pandemic.”

The revocation of the bamlanivimab EUA marks the first time since the beginning of the COVID-19 pandemic that the efficacy of a treatment has been affected by mutations in the SARS-CoV-2 virus.

Related Resource:

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.

Sincerely,

Robert L. Michel
President, Founder
The Dark Intelligence Group