InflaRx's Vilobelimab Gets Orphan Drug Status From FDA And EMA For Treament Of PG

(RTTNews) - InflaRx N.V. (IFRX) on Wednesday said its vilobelimab has been granted orphan drug designation for the treatment of Pyoderma gangrenosum (PG) by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Vilobelimab, a first-in-class monoclonal anti-C5a antibody, is being developed for the treatment of Pyoderma gangrenosum as well as severe COVID-19.

Additionally, the company said it is finalizing the design for a Phase III study in PG following an end-of-phase II meeting with the FDA.

Pyoderma gangrenosum is a rare inflammatory skin disease.

Further, a Type B meeting with the FDA to obtain guidance regarding emergency use authorization submission of vilobelimab for the treatment of Covid-19, has been scheduled in the third quarter.