InflaRx Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients

InflaRx N.V. submitted a request for Emergency Use Authorization (EUA) following encouraging interactions with the US Food and Drug Administration (FDA) at a Type B meeting held this summer. Additionally, InflaRx has been granted Fast Track designation from the FDA for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients.

The EUA submission and Fast Track designation are based on the results of the PANAMO trial, one of the largest, global, 1:1 randomized, placebo-controlled Phase III studies conducted in invasively mechanically ventilated, critically ill COVID-19 patients. The detailed results of the study were recently published in the peer-reviewed journal, The Lancet Respiratory Medicine.

Prof. Niels C. Riedemann, CEO and Founder of InflaRx, said: “The EUA submission is an exciting milestone for InflaRx in the development of our lead candidate, vilobelimab. We believe that the data from our Phase III study strongly support the potential of vilobelimab to reduce the number of deaths in critically ill, invasively mechanically ventilated COVID-19 patients. Patients are still progressing to this critical status despite the availability of vaccines and other treatments for earlier disease stages and continue to show high mortality rates.”

He continued: “The FDA’s granting of Fast Track designation for vilobelimab in this indication underscores the need for effective new therapies to treat COVID-19 patients who have progressed to critical disease with viral sepsis and organ failure. We look forward to working with the FDA on the review of our application with the goal of making vilobelimab available to patients in need.”

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby addressing unmet medical needs. Therapies that are included in this program may be eligible for more frequent interactions with the FDA to discuss the development path, and, if the program criteria are met, eligibility for a potential Rolling Review, Accelerated Approval, and Priority Review.