The EUA was based on the P-III trial (PANAMO) evaluating vilobelimab vs PBO in a ratio (1:1) in 369 patients when the drug is administered within 48 hrs. of the patient receiving either IMV or ECMO. The recommended dosage of Gohibic is 800mg, IV after dilution, given ~6 times over the treatment period
The results showed a reduction in 28-day all-cause mortality of 23.9% over PBO in critically ill invasively mechanically ventilated COVID-19 patients. The results were published in the Lancet Respiratory Medicine
InflaRx is continuing discussions with the US FDA related to the submission of an application for full approval of Gohibic. The company continues to advance vilobelimab in other indications, incl. pyoderma gangrenosum
Ref: Globe Newswire | Image: InflaRx
Related News:- InflaRx Reports Results of Vilobelimab in the P-III Part of P-II/III (PANAMO) Study for the Treatment of Severe COVID-19
