Azficel-T, an investigational therapy to cure wrinkles, has been delayed approval as US FDA sought more data on the drug, Fibrocell Science Inc announced in a press release.
Azficel-T, which is an autologous cell therapy proposed to be brandnamed as Laviv, is a biological drug to treat moderate to severe nasolabial fold wrinkles in adults.
Fibrocell Science, Inc.has received a Complete Response letter is issued by US FDA’s Center for Biologics Evaluation and Research (CBER) when the review of a file is completed seeking additional data prior to approval.
The US FDA letter requested Fibrocell Science provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T (Laviv).
Fibrocell was also requested to submit 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,” stated Declan Daly, Fibrocell Science, Inc. interim chief executive officer.
In October 9, US FDA’s Cellular, Tissue and Gene Therapies Advisory Committee reviewed azfibrocel-T (Laviv). The committee voted 11 yes to 3 no that the data presented on azfibrocel-T (Laviv) demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety, both for the proposed indication.
Fibrocell Science, Inc originally filed biologics license application (BLA) for azfibrocel-T in March 2009. The FDA is expected to make a decision whether to approve Fibrocell’s BLA for azfibrocel-T (Laviv) by January 4, 2010.
Fibrocell Therapy is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient’s own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy.
Fibroblasts are cells that contribute to the formation of connective tissue fibers. These matrix fibers are critical to the strength and elasticity of the skin.
Broadly, the regenerative effects of fibroblasts include: The ability to synthesize the extracellular matrix components and, thus, to improve skin texture; The secretion of matrix fibers, including collagen, and playing a critical role in wound healing and tissue repair.
Fibrocell prepares the Fibrocell Therapy through a streamlined process that begins with removing a small sample of cells from behind a patient’s ear and sending that sample to the Fibrocell cGMP facility.
The process expands fibroblasts into tens of millions of new cells, which are then formulated into an autologous cellular therapy. Cells are frozen and used for multiple treatment sessions.
The therapy is reintroduced into the patient’s skin by injection, which is supposed to result in an increase in the local fibroblast population, collagen formation and assists the body’s own regenerative healing process.
In controlled clinical studies, a significant improvement in the appearance of nasolabial fold wrinkles was observed after injecting Fibrocell Therapy, the company said.
Regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications.
In addition to wrinkle correction, Fibrocell has obtained statistically significant results in a Phase II/III acne scar clinical trial and a Phase II open label full face rejuvenation study. Fibrocell also has results in early burn scars and periodontal disease studies.
Fibrocell Science, Inc. is planning to continue studies for additional aesthetic and therapeutic indications for azficel-T.
Fibrocell manufactures its cell therapy at a cGMP manufacturing facility in Pennsylvania.
Fibrocell Science, Inc. is a biotechnology company focused on the development of regenerative cell therapy for aesthetic, medical and scientific applications. Fibrocell Science is engagedv in advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology.