Fibrocell Science, Inc. (OTCBB: FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted its complete response to the Complete Response (CR) letter issued by the U.S. Food & Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles.
“The study met all expectations, and importantly raised no safety concerns.”
"The submission of our response to the FDA is a significant milestone for our lead cell therapy, azficel-T," said David Pernock, Fibrocell Science Chairman and CEO. "We believe that we have now satisfied all of the FDA requirements."
One of the FDA requirements was to conduct a histopathological study examining skin after injections of azficel-T. The Company's response contained data from a 29-patient blinded study (IT-H-001). FDA participated in the design of the protocol, and consented to the unblinding of the study data. At three months, there were no unexpected results, and the study provided additional data to support the safety profile seen in the clinic.
"Azficel-T was directly compared to a placebo injection as well as untreated skin in each subject. The study results were consistent with previous clinical studies, while providing a detailed examination of azficel-T activity at the microscopic level after repeated injections," said James Merritt, M.D., Clinical Advisor to the study and Chief Medical Officer of CBR International Corp., a Colorado based research firm who provided medical advice to Fibrocell during the study. "The study met all expectations, and importantly raised no safety concerns."
According to the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem that the response from Fibrocell Science is complete.
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