Ytterligare genterapeutiskt läkemedel godkänt av FDA

Ytterligare ett genterapeutiskt läkemedel godkändes 19 december av den amerikanska läkemedelsmyndigheten FDA, Luxturna från Sparks Therapeutics. Det visar tydligt  på vilka möjligheter som gentekniken erbjuder.

Uttalandet från FDA kommissionären Scott Gottlieb visar också hur väl positionerat vi som genterapi bolag är:

”I believe gene therapy will become a mainstay in treating, and maybe curing, many of our most devastating and intractable illnesses…” and ”We’re at a turning point when it comes to this novel form of therapy and at the FDA, we’re focused on establishing the right policy framework to capitalize on this scientific opening. Next year, we’ll begin issuing a suite of disease-specific guidance documents on the development of specific gene therapy products to lay out modern and more efficient parameters – including new clinical measures – for the evaluation and review of gene therapy for different high-priority diseases where the platform is being targeted.”