InflaRx N.V. 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). InflaRx submitted the MAA to EMA in July 2023 following interactions with the rapporteur and co-rapporteur teams of the CHMP.

The MAA submission is based on the previously announced results of the multicenter Phase III PANAMO trial, one of the largest 1:1 randomized, double-blind placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.