Spark Therapeutics ( FDA ) has announced recommendations for supporting gene therapies aimed at tacking haemophilia, retinal disorders and rare diseases. It said the suggestions reflecting increasing work in gene therapy could be used by sponsors to speed a drug’s official FDA approval. The FDA has already approved the Gilead Sciences therapy from Novartis , FDA ’ Yescarta and the Luxturna therapy from Spark Therapeutics and Kymriah has now won a second approval. Spark Therapeutics commissioner 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 work in gene therapy could be used by sponsors 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 Therapeutics and Kymriah has now won a second approval. FDA commissioner Scott Gottlieb said the recommendations were intended as building blocks for a comprehensive framework for gene therapy.