F2G Announces FDA Filing Acceptance of NDA for the Treatment of Invasive Fungal Infections

Biotech company F2G announced today the FDA has accepted its NDA filing for its antfungal therapy, Olorofim. The FDA has set the Prescription Drug User Fee Act (PDUFA) date for June 17, 2023.

Olorfim was developed to treat invasive fungal infections and the NDA is supported by data and a favorable tolerability profile seen during treatment of the first 100 patients in the phase 2b open-label study, all of whom had limited or no treatment options for either proven invasive fungal infection (including aspergilllosis, lomentosporiosis, scedosporiosis, Scopulariopsis infections, and refractory extrapulmonary coccidioidomycosis) or probable pulmonary invasive aspergillosis.

The therapy’s manufacturer, F2G, is looking to fill an unmet need within the fungal infection space, especially within immunosuppressed patients who have limited or no treatment options.

It provides a new option for patients who have exhausted treatment alternatives,” F2G Chief Medical Officer John H. Rex, MD, said in a statement. “Invasive fungal infections cause substantial morbidity and mortality, particularly among immunosuppressed patients, and can prove to be lethal in also healthy individuals when they get into deeper tissues. Effective therapies do not currently exist for some of these fungi. And even when therapies exist, some patients with invasive infections may be refractory or unable to tolerate existing antifungal treatments, thus underscoring the urgent need for new and effective treatments.”

Olorofim received Breakthrough Therapy Designation for both “treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy."

The antifungal treatment space is a mature market that has not had much in the way of development of new therapies in recent years.

“Olorofim is a novel mechanism antifungal therapy from the newly discovered orotomide class,” Rex said.

Contagion spoke to Rex who offered insights into the antifungal and how this therapy could be applied in the clinical setting.