The Food and Drug Administration (FDA) in the U.S. has rejected the U.K.-based F2G’s new drug application (NDA) for the antifungal drug Olorofim, which is being produced in collaboration with Shinogi & Co. F2G is responsible for the commercial development of the drug in North America, while its Japanese partner is taking charge in the Asia-Pacific region and Europe.
In fact, at the beginning of this year, for the collaboration between the two firms, F2G received Bionow’s 2022 Investment Deal of the Year Award.
After the drug was initially submitted for approval, the regulator announced that it would be making a decision on approval on June 17. However, this week, the firm announced that the FDA has requested them to submit further data and analyses before reaching a final conclusion.
The new information requested by the agency requires time and resources that are not possible for F2G to submit within the present review period. Therefore, the agency has advised the firm to work with them to come up with a new NDA package, the company shared in a press release.
When F2G first filed an approval application, it was based on data drawn from a phase 2b study featuring the first 100 candidates in a study meant to test the efficacy of Olorofim against rare fungal mold infections that are considered difficult to treat. These included infections such as scedosporiosis, lomentosporiosis, and azole-resistant aspergillosis.
“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,” said CEO Francesco Maria Lavino. “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.”
When the company plans to resubmit the approval application, it plans to do so with improved data. F2G has recently begun its Phase III OASIS trial in which Olorofim will be compared against AmBisome and then the standard of care to test which acts better against Aspergillus fungal infections. Enrollment for the trial is now complete and will include a full dataset from all 203 participants.
Olorofim, alternatively known as F901318, is part of a new class of antifungal drugs called the orotomides and works by hindering the creation of pyrimidines by stopping the production of the dihydroorotate dehydrogenase enzyme. Pyrimidines are compounds necessary for the survival of fungi.
Due to the drug’s ability to treat a plethora of fungal infections, it was granted orphan drug designation by the EMA and the FDA. Although the drug has yet to gain formal approval from a regulatory body, it has also qualified for infectious disease product designation and breakthrough therapy designation.
Other firms apart from F2G that have recently gained interest in the antifungal market include GSK, which just this past March paid $90 million to purchase Brexafemme from Scynexis, a New Jersey-based biotech. Brexafemme has been approved in the U.S. for the treatment of a particular type of vaginal infection.
