F2G receives FDA Breakthrough Therapy designation for olorofim

F2G, an Anglo-Austrian biotech company developing therapies for life-threatening systemic fungal infections, has announced that the US Food and Drug Administration (FDA) has granted an additional Breakthrough Therapy Designation to its lead candidate, olorofim.

This designation has been granted for the indication of treatment of central nervous system (CNS) coccidioidomycosis, refractory or otherwise unable to be treated with standard of care therapy.

It is the second Breakthrough Therapy designation for olorofim, the first having been granted in November 2019 for the treatment of invasive mold 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.