Fibrocell Science, Inc has received a Complete Response letter from the US Food and Drug Administration (FDA) related to the Biologics License Application (BLA) for azficel-T, an autologous cell therapy for the treatment of moderate to severe nasolabial fold wrinkles in adults. A Complete Response letter is issued by the US FDA's Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and additional data are needed prior to approval.
The Complete Response letter requested that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls (CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred during the BLA review period, as well as revised policies and procedures regarding shipping practices, and proposed labeling.
"We are pleased with the review and will work closely with the FDA to complete the histopathology study and provide all of the requested data as quickly as possible," said Declan Daly, Fibrocell Science, Inc interim chief executive officer.
Fibrocell Science is a biotechnology company focused on the development of regenerative cell therapy for aesthetic, medical and scientific applications.