FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients.
Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune response
FDA granted EUA based on Phase III clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically ill invasively mechanically ventilated COVID-19 patients
InflaRx continues the dialogue with FDA to discuss next steps towards a Biologics License Application submission for full approval
Encouraging pre-submission meetings held with EMA in Europe; InflaRx plans to apply for full approval to treat critically ill COVID-19 patients
Company to host a conference call tomorrow, April 5th at 8:30 am EDT/2:30 pm CEST
JENA, Germany, April 04, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, said: “We are thrilled and very proud that the FDA has issued an EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug. Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation. As a consequence, we continue to see mortality rates in the range of approximately 2,000 COVID-19-reported deaths per week in the U.S. as reported by the U.S. Centers for Disease Control and Prevention. Today’s announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available to patients as rapidly as possible.”
The data supporting the EUA were based on the previously announced results of the multicenter Phase III PANAMO trial. PANAMO is one of the largest 1:1 randomized, double-blind placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. A total of 369 patients were randomly assigned to the vilobelimab treatment group (six 800-mg infusions) or the placebo group. Both groups also received standard of care, which included treatment with anti-coagulants, dexamethasone and other immunomodulators. The data 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 have been published in The Lancet Respiratory Medicine.
InflaRx continues discussions with FDA related to submission of a BLA for full approval of Gohibic in this COVID-19 indication. InflaRx has also completed encouraging meetings with the rapporteur and co-rapporteur teams of the European Committee for Medicinal Products for Human Use (CHMP) related to a planned Marketing Authorization Application with the European Medicines Agency (EMA). In addition, InflaRx is continuing to develop vilobelimab in other indications, including pyoderma gangrenosum, for which the Company is currently initiating a Phase III trial.
Prof. Renfeng Guo, M.D., Chief Scientific Officer and Founder of InflaRx, said: “This EUA is a great recognition of our COVID-19-related research, which was based on over two decades of groundbreaking work on the tissue and organ-damaging effect of the complement factor C5a as part of the body’s immune response. InflaRx will evaluate broadening our development of vilobelimab in other areas of viral lung injury and viral sepsis where the mechanism has already been researched in pre-clinical models. Our COVID-19 results underscore the anti-inflammatory potential of inhibition of the terminal C5a and C5a receptor pathway in other inflammatory diseases.”
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