FDA Might Need New Data From Eiger Bio's COVID-19 Treatment Prospect

  • Eiger BioPharmaceuticals Inc EIGR updated its planned request for emergency use authorization (EUA) of peginterferon lambda for mild-to-moderate COVID-19.
  • The FDA indicated that it is not yet able to determine whether the criteria for submitting an application and issuance of a EUA are likely to be met.
  • The FDA has indicated that it will consider any new information and data from the TOGETHER study to support a EUA and the company's plans for developing peginterferon lambda for COVID-19.
  • The company has recently generated new data and analyses from the TOGETHER study that it plans to discuss with the FDA, including further statistical modeling and efficacy analyses of the study's primary and secondary endpoints in patients treated within three days of symptom onset. 
  • Peginterferon Lambda significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits by 50% (primary endpoint) and death by 60%.
  • In addition, Eiger plans to provide new additional analyses of long-term follow-up data, including rates of rebound and incidence of long COVID, as well as an indirect comparative analysis of mortality and hospitalizations in vaccinated patients.
  • Price Action: EIGR shares are down 14.50% at $7.31 during the premarket session on the last check Tuesday.
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