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FDA-AUTHORIZED FOR EMERGENCY USE

The U.S. Food and Drug Administration 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 invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). However, GOHIBIC is not FDA-approved for this use.1

FDA AUTHORIZATION MATERIALS:

Fact Sheet for Patients and Caregivers
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Fact Sheet for Healthcare Providers
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FDA Emergency Use Authorization Letter
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IMPORTANT SAFETY INFORMATION

GOHIBIC has not been approved but has been authorized for emergency use by the FDA under an EUA for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO.1,2

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.2

What is Covid-19?

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.3

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?3

The United States FDA has made GOHIBIC available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

GOHIBIC, as a treatment for COVID-19 has not undergone the same type of review as an FDA-approved product for this indication. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic.

All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.

The EUA for GOHIBIC as a treatment for certain people with COVID-19 is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the products may no longer be used under the EUA).

WHAT IS GOHIBIC (vilobelimab)?3

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.

Contact us

If you have questions about GOHIBIC, please contact InflaRx via phone or email.

Phone: 1-888-254-0602

General Inquiries: Info.Gohibic@inflarx.com

Medical Inquiries: medinfo@inflarx.com

AUTHORIZED USE FOR GOHIBIC

The U.S. Food and Drug Administration has issued an EUA for the emergency use of GOHIBIC (vilobelimab) 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.1

IMPORTANT SAFETY INFORMATION 

Before starting GOHIBIC, tell your healthcare provider if you:

  • Have allergies

  • Have an infection other than COVID-19

  • Are pregnant or plan to become pregnant

  • Are breast-feeding or plan to breastfeed

  • Have any serious illnesses

  • Are taking any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements

Do not take GOHIBIC if you are allergic to any of its ingredients.

GOHIBIC may cause serious side effects, including:

Serious Infections: GOHIBIC is a medicine that affects your immune system. GOHIBIC can lower the ability of your immune system to fight infections other than COVID-19.

Allergic Reactions: Serious allergic reactions can happen during or after treatment with GOHIBIC. These reactions may be severe or life-threatening.

Signs and symptoms of a serious allergic reaction with GOHIBIC may include:

  • Trouble breathing

  • Rash

  • Swelling of your face, eyes, lips, mouth, tongue, and throat

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.

Please read the accompanying Fact Sheet for Patients and Caregivers for GOHIBIC™ (vilobelimab) and discuss it with your doctor. The Fact Sheet for Healthcare Providers is also available.

References: 1. GOHIBIC Fact Sheet for Healthcare Providers, InflaRx GmbH. May 2023. Available at: https://www.fda.gov/media/166824/download. 2. Emergency Use Authorization (EUA) for Vilobelimab Letter of Authorization InflaRx GmbH. April 2023. Available at: EUA 118 InflaRx GOHIBIC LOA (04122023).docx (fda.gov). 3. GOHIBIC Fact Sheet for Patients and Caregivers, InflaRx GmbH. April 2023. Available at https://www.fda.gov/media/166821/download.