Posted by Michael Wonder on 22 Oct 2020
F2G receives second US FDA breakthrough therapy designation for Olorofim
22 October 2020 - In Phase 2b development for the treatment of life-threatening fungal infections.
F2G today that the US FDA has granted an additional breakthrough therapy designation to its lead first-in-class candidate, olorofim, for the indication of ‘treatment of central nervous system coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy’.
This is the second breakthrough therapy designation for olorofim; a designation was granted previously on 11 November 2019 for ‘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’.
