title: The Regulatory Pathway for Antifungal Drugs: A US Perspective.
abstract: Although there was a flurry of new antifungal drugs approved in the early part of the last decade, the growing need for newer agents to treat systemic fungal infections has escalated due to increasing resistance to the 2 main classes of drugs developed to date and shifts in the etiology of these diseases. In addition to this microbial shift, there are more at-risk patients who are being managed in increasingly heroic ways and are thus highly susceptible to these more common resistant fungi and yeasts. However, as we acknowledge the need for new drugs to treat these desperately ill patients, there is a basic problem facing the pharmaceutical industry as it tries to balance the conundrum of antifungal development. Globally there is a relatively low, but growing, number of systemic fungal infections, which creates significant hurdles in conducting clinical trials in a timely and economical manner. In the United States, there have been some significant moves to easing these hurdles and, potentially, to bringing new drugs to the clinic more quickly and efficiently. We will discuss the current unmet clinical need and the current US regulatory positions to encourage further investment in this critical field.
authors.affiliation: TranScrip Partners LLC, Downingtown, Pennsylvania.
authors.forename: Joni
authors.initials: J
authors.lastname: Tillotson
authors.affiliation: TranScrip Partners LLC, Downingtown, Pennsylvania.
authors.forename: Glenn S
authors.initials: GS
authors.lastname: Tillotson
mesh_terms: D000935:Antifungal Agents / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration; D004345:Drug Industry / Q000331:legislation & jurisprudence; D006801:Humans; D009181:Mycoses / Q000188:drug therapy* / Q000382:microbiology; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D000935:Antifungal Agents
keywords: FDA; GAIN; QIDP; antifungal resistance; orphan drug status