Datapoint: FDA Authorizes InflaRx’s Gohibic for Critical COVID Use
The FDA last week granted InflaRx’s Gohibic an Emergency Use Authorization (EUA) to treat critically ill COVID-19 patients who require additional oxygen or mechanical ventilation. The EUA was based on Phase II trial data, which demonstrated a significant reduction in mortality and a higher likelihood of clinical improvement in severely ill patients. The drug will join Eli Lilly’s Olumiant and Roche’s Actemra in the fight against severe COVID, but Gohibic will be the first anti-C5a monoclonal antibody in the market basket, targeting the patient’s immune response rather than the virus itself. Olumiant is currently the most advantaged severe COVID therapy, holding covered or better status for 72% of all insured lives under the pharmacy benefit, vs. Actemra’s 58%.
SOURCE: MMIT Analytics, as of 4/5/23