- German biotech InflaRx N.V. ( NASDAQ: IFRX ) announced on Wednesday that the FDA agreed for a Type B meeting as the company seeks emergency use authorization for its COVID-19 therapy, vilobelimab
- The company has engaged the agency to discuss future regulatory path for vilobelimab in COVID-19 after its multi-national PANAMO study for mechanically ventilated patients with severe form of the disease generated favorable Phase 3 results early this year.
- The FDA has scheduled a Type B meeting for early Q3 to provide guidance on a potential emergency use authorization submission.
- Meanwhile, the discussions with the European Medicines Agency (EMA) are currently underway targeting a regulatory submission for the same indication.
- Updating on the development of vilobelimab for rare skin disorder, pyoderma gangrenosum, InflaRx ( IFRX ) said that the company is now finalizing the design for a Phase III trial.
- That was after an end-of-phase II meeting in which the FDA supported a randomized, controlled late-stage study and offered to review the study protocol.
- Read more on the topline data from PANAMO study.
For further details see:
InflaRx granted FDA Type B meeting to discuss submissions for COVID therapy