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October 12, 2009
A new treatment for filling in the wrinkles on an aging face has been reviewed by the FDA's Gene Therapies Advisory Committee. The therapy, called azfibrocel-T (Laviv), takes a patient's own fibroblast cells in order to grow more cells in a laboratory environment. The cells are then injected back into the patient where they stimulate the growth of new collagen.
Fibrocell Science (formerly known as Isolagen), the company that developed the process, reported in a press release that the FDA committee voted 11 to 3 that the submitted data show efficacy, and 6 to 8 that the data demonstrated safety. The company is currently seeking approval for use in wrinkles of the nasolabial fold. "We will continue to work closely with the FDA following the discussions and recommendations from today's Advisory Committee meeting," said Declan Daly, Fibrocell Science, interim chief executive officer.
Although it is not binding, the Committee's recommendation will be considered by the FDA as the agency completes its review of the BLA for azfibrocel-T, which was originally filed in March 2009. The FDA is expected to make a decision whether to approve Fibrocell's biologics license application for azfibrocel-T by January 4, 2010.
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