Fibrocell Science, Inc., a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today 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.
“If approved, azficel-T will be the first and only personalized cell-based aesthetic treatment.”
"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.