The NDA was accepted by the regulatory agency for review with a PDUFA target action date set for 17 June 2023.
As per the CRL, the regulatory body was not able to approve olorofim at this time, and sought further data and analyses.
The FDA encouraged F2G to work with the agency and plan for the new analyses and build the NDA package.
Under the initial NDA package, data from the first 100 patients enrolled in the then-ongoing Phase 2b single-arm, open-label study (Study 32, NCT03583164) was included.
With Study 32 completing enrollment of a total of 203 patients, the company plans to submit the full data set as part of the revised NDA package.
A leading candidate of F2G from the orotomide class, olorofim is intended for patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, lomentosporiosis as well as scedosporiosis.
F2G CEO Francesco Maria Lavino said: “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives.
“We are assessing the details of the CRL and we plan to meet with the FDA to discuss it further, but we are confident that we can identify a regulatory path forward in the US.”
F2G along with its partner Shionogi & Co is also enrolling patients with proven or probable invasive aspergillosis in a global Phase III trial (OASIS) to compare olorofim against AmBisome followed by standard of care in treating aspergillosis.
F2G gains commercial responsibility for olorofim in North America while Shionogi in Asia Pacific and Europe.