F2G Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its new drug application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options. \n\n\n\nF2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 17, 2023. \n\n\n\nThe NDA is supported by strong efficacy data and a good 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 aspergillosis, lomentosporiosis, scedosporiosis, Scopulariopsis infections, and refractory extrapulmonary coccidioidomycosis) or probable pulmonary invasive aspergillosis. \n\n\n\nA new option\n\n\n\n“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,” said John H. Rex, F2G’s chief medical officer. \n\n\n\n“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. \n\n\n\n“Olorofim is a novel mechanism antifungal therapy from the newly discovered orotomide class. It provides a new option for patients who have exhausted treatment alternatives.” \n\n\n\nMajor milestone toward F2G goal\n\n\n\nFrancesco Maria Lavino, chief executive officer of F2G, added: “We are committed to addressing rare fungal infections, and the acceptance of filing of olorofim NDA for use in this well-defined and high-need population marks a major milestone toward our goal of bringing new options to these patients. We are building an experienced commercial team in preparation for U.S. launch, pending FDA approval. If approved, olorofim will be the first of a new class of antifungal drugs.” \n\n\n\nOlorofim is the only antifungal medication to be awarded breakthrough therapy designation by the FDA. Olorofim works through a novel mechanism of action, different from existing classes of antifungals, exerting fungal cell death through inhibition of the enzyme dihydroorotate dehydrogenase (DHODH) in the pyrimidine synthesis pathway. It is active in vitro against Aspergillus spp. (including azole-resistant and cryptic species), rare molds (e.g., Lomentospora prolificans, Scedosporium spp., Scopulariopsis spp.), and dimorphic fungi (e.g., Coccidioides spp.).