Fibrocell Science Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, today announced it has submitted its complete response to the U.S. Food and Drug Administration’s (FDA) concerning the company’s Biologics License Application for azficel-T.
Submitting the response brings the company into full compliance with the FDA in regards to azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and winkles.
“The submission of our response to the FDA is a significant milestone for our lead cell therapy, azficel-T,” David Pernock, Fibrocell Science chairman and CEO stated in the press release. “We believe that we have now satisfied all of the FDA requirements.”
One of the FDA requirements was to conduct a histopathological study to examine the skin after the administration of injections of azficel-T. In the clinical study, azficel-T was compared to a placebo and untreated skin in each of the 29 patients. The company said the results were consistent with previous clinical studies, and that at three months the study provided sufficient data to support the 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.
For more information visit www.fibrocellscience.com