Limited Rollout Planned For Fibrocell's Newly Approved Aesthetic Cellular Therapy
This article was originally published in The Pink Sheet Daily
The initial indication for laViv is treatment of nasolabial fold wrinkles, but Fibrocell is eyeing additional indications for its autologous cell therapy.
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Fibrocell Provides Final Data To Resolve FDA Concerns On Its Autologous Stem Cell Therapy For Facial Wrinkles
The biotech hopes next to advance its technology into treatment of acne scarring; the laViv PDUFA date is June 22.
Fibrocell is hoping to extend use of its autologous cell therapy azficel-T, currently under FDA review for treatment of nasolabial fold wrinkles, into the acne scar market. The company announced the submission of a clinical study report to FDA communicating positive results of a Phase II/III trial of azficel-T for moderate to severe acne scars on Aug. 9. The placebo-controlled, Phase II/III study of 109 patients compared response to three injections of azficel-T to one half of the patient's face with placebo injections on the other half. Results were statistically significant on both co-primary endpoints: live acne scarring assessment by patients, 43 percent of whom reported response on the treated side of the face versus just 18 percent for the placebo side, and by evaluators, who found improvement in 59 percent of the treated sides and 42 percent of the placebo sides. No serious side effects were noted. Fibrocell is in the process of shoring up its BLA for the autologous cell therapy for moderate to severe nasolabial fold wrinkles, which received a "complete response" letter on Dec. 21, 2009. FDA requested a histology study in addition to manufacturing, shipping and labeling information. The company, formerly known as Isolagen, reported in July that the histology study comparing azficel-T-treated tissue with saline-treated tissue was fully enrolled with 29 patients and was on target for submission to CBER in the fourth quarter of 2010
Advisory committee votes that Laviv (azfibrocel-T) is effective in improving nasolabial fold wrinkles, but that safety data are too limited to be relied upon - especially considering the inevitably widespread off-label use.