Posted by Michael Wonder on 10 Jun 2020
F2G’s olorofim receives both FDA orphan drug designation for Coccidioidomycosis (Valley fever) and FDA QIDP designation for multiple fungal infections
10 June 2020 - Olorofim is currently in Phase 2b development for the treatment of life-threatening fungal infections.
F2G announced today that following the granting of breakthrough therapy designation in November (the first anti-fungal ever to achieve such a designation), the U.S. FDA has also granted qualified infectious disease product designation to its lead first-in-class candidate, olorofim (formerly F901318) for the following requested indications:
- Invasive aspergillosis
- Invasive scedosporiosis
- Invasive lomentosporiosis
- Coccidioidomycosis
- Invasive disease due to Scopulariopsis species
- Invasive fusariosis
