The US Food and Drug Administration ( FDA ) has announced recommendations for supporting gene therapies aimed at tacking haemophilia , retinal disorders and rare diseases . “Broadly speaking, a major issue facing the field in general relates to reimbursement for approval products, some of which involve a high cost for treatment,” ​Kavanagh told us. It said the suggestions reflecting increasing interest in gene therapy could be used by manufacturers to speed a drug ’s official FDA approval . The FDA has already approved the Kymriah therapy from Novartis , Gilead Sciences ’ Yescarta and the Luxturna therapy from Spark , and Kymriah has now won a second approval . FDA Administrator Scott Gottlieb said the recommendations were intended as building blocks for a comprehensive framework for gene therapy .
The US Food and Drug Administration ( FDA ) has announced recommendations for supporting gene therapies aimed at tacking haemophilia , retinal disorders and rare diseases . It said the suggestions reflecting increasing interest in gene therapy could be used by manufacturers to speed a drug ’s official FDA approval . The FDA has already approved the Kymriah therapy from Novartis , Gilead Sciences ’ Yescarta and the Luxturna therapy from Spark , and Kymriah has now won a second approval . FDA Administrator Scott Gottlieb said the recommendations were intended as building blocks for a comprehensive framework for gene therapy .