InflaRx N.V. (IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, Wednesday said the European Medicines Agency or EMA has validated its Marketing Authorization Application or MAA for Vilobelimab to treat Critically Ill COVID-19 Patients.
In pre-market activity on Nasdaq, InflaRx shares were gaining around 5 percent to trade at $3.9260.
The MAA for vilobelimab, which was submitted to EMA in July, is for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome or ARDS receiving invasive mechanical ventilation or IMV or extracorporeal membrane oxygenation or ECMO.
The application is now under regulatory review by the European Committee for Medicinal Products for Human Use or CHMP under the centralized procedure, which applies to all 27 member states of the European Union.
InflaRx submitted the MAA 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, a 1:1 randomized, double-blind placebo-controlled trial 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.
The data were published in The Lancet Respiratory Medicine.
Gohibic (vilobelimab) has received an EUA in the U.S. for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO.
InflaRx said it is continuing discussions with the Food and Drug Administration related to the submission of a Biologics License Application for a potential future full approval of Gohibic (vilobelimab) in the United States.
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