InflaRx MAA for vilobelimab under review by EMA

InflaRx announced that the Company has submitted a Marketing Authorization Application, MAA, for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome, ARDS, receiving invasive mechanical ventilation, IMV, or extracorporeal membrane oxygenation, ECMO, and that the European Medicines Agency, EMA, has validated the MAA. This means that the application is now under regulatory review by the European Committee for Medicinal Products for Human Use, CHMP, under the centralized procedure, which applies to all 27 member states of the European Union, EU. “We are pleased that EMA has accepted our MAA submission and that it is now under review. By targeting the complement component C5a, vilobelimab blocks what is believed to be a key mediator of the tissue damaging inflammatory host response induced by severe SARS-CoV-2 infection. Based on the data from our Phase III trial, we believe that our treatment approach can make a meaningful difference for critically ill COVID-19 patients who are invasively mechanically ventilated,” said Dr. Camilla Chong, Chief Medical Officer of InflaRx.