FDA Fast Track Designation for Basilea's Broad-spectrum Water-soluble Antifungal BAL8557
Basilea Pharmaceutica Ltd. announced that it received fast track designation from the U.S. food and Drug Administration (FDA) for its broad-spectrum antifungal BAL8557. BAL8557's extended antifungal spectrum covers most yeasts and molds including fluconazole resistant candida strains, aspergillus and zygomyces that cause serious infections in patients with a weakened immune system. BAL8557 is water-soluble and can be given by injection or orally. It is highly bio-available and can be administered in convenient once-daily or once-weekly dosing regimens. BAL8557 also has potentially less drug-drug interactions than a number of other drugs in current use.
"We have a broad product development strategy for invasive yeast and mold infections. We also recognize that patients with such infections and impaired renal function have limited treatment options because many existing drugs can further impair kidney function. In contrast, our injectable form of BAL8557 is a water-based formulation without additives known to damage kidney function. BAL8557 is designated as a fast track product because it can provide potential benefit for the treatment of invasive fungal infections in patients with moderate to severe renal impairment. BAL8557 is our second late stage hospital anti-infective drug with fast track status, highlighting our commitment as a leading anti-infectives company to develop drugs for high medical need", commented Dr. Anthony Man, Basilea's CEO.
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