The U.S. Food and Drug Administration has issued an EUA for the emergency use of GOHIBIC (vilobelimab) 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).
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.
GOHIBIC is an investigational medicine used 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). GOHIBIC is investigational because it is still being studied. GOHIBIC is not FDA-approved for any indication, including for the treatment of COVID-19.
There is limited information known about the safety or effectiveness of using GOHIBIC to treat people in the hospital with COVID-19. Available results from clinical trials in adults indicate that treatment with GOHIBIC may decrease the risk of dying in hospitalized adults with COVID-19 when initiated within 48 hours of receiving IMV or ECMO. The safety and effectiveness of GOHIBIC have not been studied in children hospitalized with COVID-19.
The FDA has authorized the emergency use of GOHIBIC for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO under an EUA [FDA Press Release]. GOHIBIC is not FDA-approved for any indication, including the treatment of COVID-19. GOHIBIC is not authorized for COVID-19 patients younger than 18 years of age. Talk to your healthcare provider about your options or if you have any questions. It is your choice for you to take GOHIBIC or stop it at any time.
COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through contact with another person who has the virus. To learn more about COVID-19, ask your healthcare provider. You may also visit https://www.cdc.gov/COVID19 or contact your local or state public health department.
Before starting GOHIBIC, tell your healthcare provider if you:
Do not take GOHIBIC if you are allergic to any of its ingredients.
GOHIBIC may cause serious side effects, including:
Signs and symptoms of a serious allergic reaction with GOHIBIC may include:
The most common side effects of GOHIBIC include:
Lung infection, sepsis, sudden confusion, sudden lung artery blockage, high blood pressure, collapsed lung, venous blood clotting (usually in the leg), herpes infection, certain infections caused by enterococci, urinary tract infection, low blood oxygenation, low platelets, the presence of air in the space in the chest between the two lungs, infection of the respiratory tract, heart arrythmia, constipation, and rash.
Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to InflaRx by calling 1-888-254-0602.
Please also provide a copy of this form to InflaRx GmbH at pvusa@inflarx.de.
