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FDA Requires Additional Data On Merck COVID-19 Drug, EUA Moved Back

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  • Merck & Co Inc (NYSE: MRK) had reported a significant snag in its latest annual filing (10K), wherein the company has received feedback from the FDA regarding its COVID-19 drug, MK-7110.
  • The agency has asked for additional data beyond the study conducted by OncoImmune to support a potential emergency use application.
  • Hence following the feedback, Merck no longer expects to supply the U.S. government with MK-7110 in the first half of 2021.
  • OncoImmune reported top-line findings from an interim efficacy analysis of Phase 3 study of 203 participants.
  • Data showed that hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status than placebo.
  • The risk of death or respiratory failure was reduced by more than 50%.
  • Merck has already ditched a vaccine program for COVID-19 after early trials showed both vaccines generated inferior immune responses in people who had recovered from COVID-19 as well as those reported for other COVID-19 vaccines.
  • The company said it is “actively working with FDA to address the agency’s comments.”
  • Merck spent $425 million to buy OncoImmune and the drug last year November.
  • See 10K here.
  • Price Action: MRK is trading 1.72% at $73.33 in market trading hours on the last check Friday.
 

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Posted-In: Covid-19Biotech News Health Care FDA General

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