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FDA OKs autologous cell therapy

Article-FDA OKs autologous cell therapy

Exton, Pa. — Fibrocell Science has won Food and Drug Administration (FDA) approval for an injectable wrinkle treatment that uses a patient’s own cells, reports.

LaVív (azficel-T) is a personalized aesthetic cell therapy for improving the appearance of moderate-to-severe nasolabial folds in adults, the company states.

The treatment uses a patient’s own fibroblasts, which are extracted from behind the ear and sent to Fibrocell’s laboratory, then multiplied and harvested in a process that take about 50 days, reports. When injected, the new cells produce collagen and elastin.

Fibrocell said approval was based in part on the combined results of two identical phase 3 studies of 421 patients. Treatment was administered in three sessions approximately five weeks apart. Using stringent co-primary endpoints based on the investigators’ and patients’ assessments, a significantly greater proportion of patients demonstrated a positive response to treatment with laVív than with placebo. How long the effect may last beyond six months is a topic of further study, according to the statement.

As part of a postmarketing requirement, Fibrocell will establish a registry of approximately 2,700 patients to further evaluate the product’s safety.

The treatment failed to win FDA approval in 2009, and the agency asked for more safety data, Bloomberg reports. LaVív will enter an aesthetic marketplace already occupied by neurotoxins Botox (onabotulinumtoxinA, Allergan) and Dysport (abobotulinumtoxinA, Medicis), as well as wrinkle fillers that use animal collagens or chemicals.

The statement notes that laVív will soon be available through trained clinical investigators in select metropolitan areas, and that the number of cities will grow as manufacturing capacity expands and more physicians are trained.

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