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.

GOHIBIC has been associated with an increase of serious infections. Hypersensitive reactions have been reported. The most common adverse reactions (incidence ≥ 3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, and herpes simplex.  Additional safety information can be found at gohibic.com.

gohibic.com

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