InflaRx (IFRX) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization under exceptional circumstances for Gohibic, or vilobelimab, to treat adults with Covid-induced acute respiratory distress syndrome.
The proposed indication for the drug is for patients already receiving systemic corticosteroids and invasive mechanical ventilation, the company said.
The company said it expects the European Commission to adopt the committee's positive opinion and issue a marketing authorization for the indication within 67 days.
The positive opinion follows results of a phase 3 trial which showed a 23.9% reduction in mortality compared to placebo over 28 days.
The company's shares were up more than 10% in recent Friday premarket activity.
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