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F2G preps NDA for first new antifungal in 20 years on solid phase III

Three years on from the rebuff of a U.S. FDA complete response letter, F2G Ltd. now has the data needed to resubmit the NDA for the first novel antifungal drug...

Three years on from the rebuff of a U.S. FDA complete response letter, F2G Ltd. now has the data needed to resubmit the NDA for the first novel antifungal drug in more than two decades. Along with partner Shionogi & Co. Ltd., F2G has released positive phase III results for orally administered olorofim, showing noninferiority against I.V.-administered Ambisome (amphotericin B, Gilead Sciences Inc.) in patients with refractory aspergillosis infections, or who were unsuitable for mainstay azole therapy.