F2G’s Olorofim Receives FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP Designation for Multiple Fungal Infections
F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, announced today that following the granting of Breakthrough Therapy designation in November (the first antifungal ever to achieve such a designation), the U.S. Food and Drug Administration (FDA) has also granted Qualified Infectious Disease Product (QIDP) designation to its lead first-in-class candidate, olorofim (formerly F901318) for the following requested indications:
- Invasive aspergillosis
- Invasive scedosporiosis
- Invasive lomentosporiosis
- Invasive disease due to Scopulariopsis species
- Invasive fusariosis
In addition, F2G has been granted Orphan Drug Designation for Coccidioidomycosis (Valley Fever). This development follows the FDA's granting of Orphan Drug Designation to olorofim announced in March 2020 for the treatment of invasive aspergillosis and Lomentospora/Scedosporium infections.
The QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for the development of new antifungal and antibacterial drugs including eligibility for an additional five years of marketing exclusivity and Fast Track designation.
To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. These listed qualified pathogens include the Coccidioides, Aspergillus, Scedosporium and Lomentospora species, which have the potential to pose a serious threat to public health.
Commenting on the news, Ian Nicholson, CEO of F2G Ltd, said, "Today's news is a very significant milestone for the F2G team. The recently granted QIPD and Orphan Drug designations are further testament to the potential that olorofim represents in treating patients suffering from serious and life-threatening fungal infections such as Valley Fever. These priority review and fast track designations give F2G further momentum in the development of olorofim as we continue to work with the FDA to deliver this potentially life-saving therapy to critically ill patients in need."
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