Olorofim FDA Approval Status
Last updated by Judith Stewart, BPharm on June 20, 2023.
FDA Approved: No
Generic name: olorofim
Company: F2G Inc.
Treatment for: Fungal Infections
Olorofim is a the first of the new orotomide class of antifungals in development for the treatment of difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections.
- Olorofim works by exerting fungal cell death through inhibition of the enzyme dihydroorotate dehydrogenase (DHODH) in the pyrimidine synthesis pathway.
- Olorofim 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.).
- Olorofim has received orphan drug designation from the FDA for the treatment of coccidioidomycosis, scedosporiosis (including lomentosporiosis), invasive Scopulariopsis, and invasive aspergillosis.
- Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.
- Olorofim has also 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, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species; and treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.
- On June 19, 2023, F2G Ltd. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for olorofim. According to the CRL, the FDA was not able to approve olorofim, and has requested additional data and analyses.
Development timeline for olorofim
Further information
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