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InflaRx is applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR
The U.S. FDA has issued an Emergency Use Authorization (EUA) for GOHIBIC (vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation. GOHIBIC is not FDA approved for this use.
Jena, Germany, January 23, 2025 – InflaRx N.V. (Nasdaq: IFRX), a biop ...
Jena, Germany, January 15, 2025 – InflaRx N.V. (N ...
Jena, Germany, January 7, 2025 – InflaRx N.V. (Nasdaq: IFRX), a bioph ...
Jena, Germany, December 20, 2024 – InflaRx N.V. ( ...
In April 2023, The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) of GOHIBIC 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). However, GOHIBIC is not FDA-approved for this use.
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.
The most common adverse reactions (incidence ≥23%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis and herpes simplex. Additional safety information, including AEs, can be found at gohibic.com.
Fact Sheet for U.S. Healthcare Providers
Fact Sheet for U.S. Patients and Caregivers
U.S. Food and Drug Administration Letter of Authorization
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