Posted by Michael Wonder on 11 Nov 2019
F2G receives US FDA breakthrough therapy designation for Olorofim
11 November 2019 - First anti-fungal agent to receive breakthrough therapy designation.
2G announced today that the US FDA has granted breakthrough therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the indication of ‘Treatment of invasive mould infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation.
Olorofim is currently being investigated in an open-label single-arm Phase 2b study in patients with proven invasive fungal disease or probable invasive aspergillosis and either refractory disease, resistance, or intolerance to available agents.
