Fibrocell Science, Inc. (OTCBB: FCSC), a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company's complete response submission for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles. The Prescription Drug User Fee Act (PDUFA) date is June 22, 2011.
"We are pleased that our complete response was accepted and look forward to working closely with the FDA through the review process," said David Pernock, Fibrocell Science Chairman and CEO. "If approved, azficel-T will be the first and only personalized cell-based aesthetic treatment."
The Fibrocell Science scientific approach results in a replenishment of the patient's own fibroblasts, the cells that are responsible for releasing collagen, elastin and hyaluronic acid which add strength and elasticity to the skin. The Company is planning to conduct studies on applying its autologous fibroblast technology in additional areas including further aesthetic applications, and for the treatment of restrictive burn scars, acne scars, and periodontal disease.
About The Fibrocell Science Technology
Fibroblasts are cells that contribute to the formation of connective tissue fibers, and regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications.
Fibrocell Science's lead therapy, azficel-T, is an investigational autologous (personalized) cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. Azficel-T is currently under review by the U.S. Food & Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. Also, the Company recently submitted a clinical study report to the FDA for a Phase II/III trial of azficel-T in acne scarring.