Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News F2G Faces FDA Setback Over Antifungal Range

F2G Faces FDA Setback Over Antifungal Range

27th June 2023

Austria based Biotechnology company, F2G, has hit a barrier in their mission to launch an entirely new group of antifungal products.

One of the products in the new range, Olorofim, was scheduled for clearance on the 17th of June, however, instead, the FDA has asked for more information and analysis before it can reevaluate its authorisation status.

F2G expressed that “the FDA encouraged” them to work together “to plan for the new analyses and develop the NDA package”, and with further details submitted regarding outcomes of the first 100 patients in phase 2b research, F2G filed the approval proposal.

Francesco Maria Lavino, the company’s Chief Executive Officer, said that “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.”

While they address this, the company is beginning to take applications for phase 3 research which does a side-by-side evaluation of Olorofim and AmBisome, which is already authorised, for those with or at risk of invasive aspergillosis.

© Copyright 2010-2021 Zenopa LTD. All Rights Reserved.

We currently have 9 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.