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InflaRx Announces Plans to Apply for Emergency Use Authorization from the US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients
Completed encouraging Type B meeting with US FDAApplication for EUA planned to be submitted in Q3 2022 JENA, Germany, July 26, 2022 (GLOBE NEWSWIRE) --
About this update from Inflarx N.v.
[{"type":"text","content":"Completed encouraging Type B meeting with US FDAApplication for EUA planned to be submitted in Q3 2022 JENA, Germany, July 26, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced plans to submit a request for Emergency Use Authorization (EUA) following encouraging interactions with the US Food and Drug Administration (FDA) at a recently held Type B meeting. 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. “With emerging COVID-19 variants and cases and hospitalizations again on the rise, there remains an urgent need for new treatment options, especially for the sickest patients who suffer from an inflammatory response, leading to organ failure. Our constructive interactions with the FDA and the helpful guidance they provided have encouraged us to move forward with applying for EUA for vilobelimab in critically ill COVID-19 patients,” said Prof. Niels C. Riedemann, CEO and Founder of InflaRx. “Our team has committed to submitting the request for an EUA by the end of Q3 2022 and is dedicated to achieving that ambitious goal.” The company had previously announced encouraging topline results from the PANAMO Phase III study, an international, double-blind, placebo-controlled, randomized clinical trial investigating vilobelimab in invasively mechanically ventilated COVID-19 patients. The primary efficacy endpoint was 28-day all-cause mortality. In this trial, vilobelimab treatment resulted in a 23.9% relative reduction in 28-day all-cause mortality when compared to the placebo arm in the global data set (n=368 patients). A p...