Fibrocell Gets FDA Complete Response Letter For azficel-T

Fibrocell Science has received a Complete Response letter from the 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.

Reportedly, in the letter, the FDA has requested Fibrocell Science to provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T.

Furthermore, FDA has also requested to finalised 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.

Declan Daly, interim CEO of Fibrocell Science, said: “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.”