"We welcome our new Board members and value their contributions during this transformational time for the Company," said Declan Daly. "We have a major near-term company milestone this week when the FDA advisory committee will review azfibrocel-T, our lead investigational cell therapy for the treatment of nasolabial fold wrinkles. We look forward to gaining Committee input, and working with the FDA as we seek to bring this novel aesthetic therapy to the market in 2010."
BLA Review Underway; FDA Advisory Committee Scheduled
In May 2009, the FDA accepted for full review the BLA of azfibrocel-T for the treatment of moderate to severe nasolabial fold wrinkles. The Prescription Drug User Fee Act (PDUFA) target date for FDA response is January 4, 2010.
The azfibrocel-T pivotal Phase III safety and efficacy studies (IT-R-005; IT-R-006) evaluated a total of 421 individuals at 13 clinical sites across the United States. Study results demonstrated a significant difference in therapy results compared to placebo (p < 0.01). No serious adverse events were reported.
The Cellular, Tissue and Gene Therapies Advisory Committee Meeting will be held on October 9, 2009 in Bethesda, Maryland. Background materials for the meeting are expected to be made available by the FDA on www.fda.gov no later than two business days before the meeting.
Azfibrocel-T, proposed brand name Laviv(TM), is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy. Fibroblasts are cells which contribute to the formation of connective tissue fibers. The therapy is currently under review by the FDA for the treatment of nasolabial
|SOURCE Fibrocell Science, Inc.|
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