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Merck/Ridgeback’s COVID-19 Drug Molnupiravir Met EUA Bar, But More Data Needed For Full Approval – US FDA

 
• By Sue Sutter

Reviewers believed it was worth making the oral antiviral available for second-line use under the relatively low bar for emergency authorization despite the drug’s significant potential risks, ‘modest benefit’ and ‘unexplained difference’ in efficacy results from the interim and full analysis populations in the pivotal trial.

Uneven bars
Molnupiravir met the low bar for emergency authorization but will need more data to surmount the higher bar for full approval. • Source: Alamy

Merck & Co., Inc. and Ridgeback Biotherapeutics LP’s antiviral molnupiravir satisfied the relatively low threshold for US emergency use authorization as a COVID-19 treatment, but it appears considerably more data, and more convincing data, would be needed to meet the higher standard for full drug approval.

In a decision memorandum, US Food and Drug Administration reviewers cited the “unexplained difference in efficacy results from the...

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