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Tuesday, April 4, 2023

InflaRx Gets Emergency Use Authorization for Treatment of Critically Ill COVID-19 Patients

 

  • Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune response

  • FDA granted EUA based on Phase III clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically ill invasively mechanically ventilated COVID-19 patients

  • InflaRx continues the dialogue with FDA to discuss next steps towards a Biologics License Application submission for full approval

  • Encouraging pre-submission meetings held with EMA in Europe; InflaRx plans to apply for full approval to treat critically ill COVID-19 patients

  • Company to host a conference call tomorrow, April 5th at 8:30 am EDT/2:30 pm CEST

InflaRx will host a conference call to discuss today’s news on April 5th at 8:30 am EDT (2:30 pm CEST). To participate in the conference call, participants may pre-register here and will receive a dedicated link and dial-in details to easily and quickly access the call. A replay will be available on the InflaRx website in the Investors - Events & Presentations section.

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