InflaRx Announces Plans to Apply for Emergency Use Authorization from the US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients
As previously announced, the company had requested the meeting to discuss a potential EUA submission and the development of its first-in-class anti-C5a monoclonal antibody vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients.
- As previously announced, the company had requested the meeting to discuss a potential EUA submission and the development of its first-in-class anti-C5a monoclonal antibody vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients.
- In the meeting with the FDA, the company discussed in detail the completed Phase III part of the PANAMO study in invasively mechanically ventilated, critically ill COVID-19 patients.
- The company also obtained guidance from the agency on deliverables related to its planned submission for EUA.
- InflaRx also committed to additional discussions with the agency regarding its further development of vilobelimab for critically ill invasively mechanically ventilated COVID-19 patients.