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news.The agency 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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The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee has reviewed Fibrocell Science’s azfibrocel-T, an autologous cell therapy being investigated for the treatment of moderate-to-severe nasolabial fold wrinkles in adults.
Reportedly, the committee has 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).
The company said that 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.
Declan Daly, interim CEO of Fibrocell, said: “We will continue to work closely with the FDA following the discussions and recommendations from today’s Advisory Committee meeting.”