Fibrocell's Wrinkle Drug Underlines Challenges Of Seeking Aesthetic Claims
An FDA advisory committee made very clear that the bar should be much higher for novel products proposed for aesthetic indications than for drugs to treat diseases during the Oct. 9 review of Fibrocell Science's wrinkle therapy Laviv (azfibrocel-T)
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Absence of data about what happens under the surface of the skin when the cell therapy for wrinkles is injected raised safety concerns.
Fibrocell Provides Final Data To Resolve FDA Concerns On Its Autologous Stem Cell Therapy For Facial Wrinkles
The biotech hopes next to advance its technology into treatment of acne scarring; the laViv PDUFA date is June 22.
As the most advanced stem cell therapies, known collectively these days as "regenerative medicine," edge into the clinic, much about the field remains unresolved – including basic regulatory questions and whether the therapies, which hope to restore circulation to ischemic tissue or function to damaged nerves, for example, will even work in humans.