IFRX - InflaRx's Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA) | Benzinga
- MAA for vilobelimab was submitted in July
- MAA has been validated by EMA and is now under review
- Regulatory submission based on pivotal data from PANAMO Phase III trial
- Company announces attendance at upcoming scientific and investor events
JENA, Germany, Aug. 30, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced today 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. The data were published in The Lancet Respiratory Medicine.
"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.
"We look forward to continuing to work closely with EMA throughout the MAA review process, which is another important step toward our goal of bringing a potential treatment option to certain critically ill COVID-19 patients in Europe after having recently received an Emergency Use Authorization (EUA) in the United States," added Derval O'Carroll, Senior Vice President and Global Head of Regulatory Affairs & Compliance at InflaRx.
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. The Company is continuing discussions with the Food and Drug Administration (FDA) related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic (vilobelimab) in the United States. For additional information related to the EUA, please visit www.Gohibic.com
Upcoming scientific and investor events
InflaRx's management will participate in the following conferences in the coming weeks:
World Antimicrobial Resistance Congress
September 7-8, 2023, Philadelphia, PA, USA
- Panel discussion, September 7, 11:20 am EDT with Prof. Niels C. Riedemann, CEO
H.C. Wainwright 25th Annual Global Investment Conference
September 11-13, 2023, New York, NY, USA
- Company presentation on September 11th, 11:00 am EDT (webcast)
7th Annual Complement-Based Drug Development Summit
September 11-13, 2023, Boston, MA, USA
- Presentation "The Life-Saving Anti-Inflammatory Potential of Blocking the C5a / ...