Jena, Germany, April 04, 2023 – 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.”
Availability and Distribution Information
InflaRx has a supply of Gohibic (vilobelimab) available and is working to ramp up production at its third-party manufacturer to roll out supply in the U.S. as soon as possible. The Company is assessing all options for supplying drug to hospitals to enable the treatment of patients. The Company will provide more detailed information once available.
About the Emergency Use Authorization (EUA) for Gohibic (vilobelimab)
The US Food and Drug Administration (FDA) has issued an EUA for the emergency use of Gohibic for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV, or ECMO.
Gohibic has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV, or ECMO.
The emergency use of Gohibic is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
Important Information About Gohibic (vilobelimab)
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody that has been granted an EUA for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Vilobelimab is an investigational drug that has not been approved by the FDA for any indication including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using Gohibic to treat people in the hospital with COVID-19.
Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the Gohibic website (www.Gohibic.com).
Important Safety Information About Gohibic (vilobelimab)
There are limited clinical data available for Gohibic. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with Gohibic use.
Gohibic has been associated with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with Gohibic.
Hypersensitivity reactions have been observed with Gohibic. If a severe hypersensitivity reaction occurs, administration of Gohibic should be discontinued and appropriate therapy initiated.
The most common adverse reactions (incidence ≥3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during Gohibic treatment and considered to be potentially attributable to Gohibic.
Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: firstname.lastname@example.org
For additional important safety information, please visit www.Gohibic.com
Source: InflaRx N.V.
Posted: April 2023
Gohibic (vilobelimab) FDA Approval History