Business Standard - A treatment that can stop patients from going blind is poised to be the first gene therapy for an inherited condition approved in the US, in what would be a major scientific milestone — and also open the door for record-breaking drug prices and novel ways to pay for them. Spark Therapeutics Inc’s Luxturna therapy crossed a key hurdle Thursday when it won backing from a group of advisers to the US Food and Drug Administration (FDA). After discussing the trial design, treatment procedure and safety profile, the panel of 16 experts voted unanimously that the drug’s benefits outweighed its risks. If the FDA, which now has until Jan 12 to make a final decision, says yes to Luxturna, it will be a landmark moment for the medical industry... >>>
Nessun commento:
Posta un commento