Fibrocell Science, Inc. (OTCBB: FCSC) announced today that the U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee reviewed azfibrocel-T, an autologous cell therapy being investigated for the treatment of moderate to severe nasolabial fold wrinkles in adults. The committee voted 11 yes to 3 no that the data presented on azfibrocel-T demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety, both for the proposed indication. The FDA is currently evaluating the USAN name, azfibrocel-T, and a proposed brand name, Laviv(TM).
"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, Inc. 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 (BLA) for azfibrocel-T by January 4, 2010.
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