Wednesday, 22 Jun 2011 09:15am EDT

Fibrocell Science, Inc. announced that the U.S. Food and Drug Administration (FDA) approved the Company’s Biologics License Application for its product, laV?v (azficel-T). laV?v is the first and only personalized aesthetic cell therapy approved by the FDA for the improvement of the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults. In clinical trials, laV?v was well tolerated with the majority of adverse events being injection-site reactions that were of mild to moderate intensity and resolved within one week. The FDA approval was based in part on the combined results of two identical Phase III multi-center, randomized, double-blind, placebo-controlled 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 laV?v than with placebo. Based on these trials, laV?v effectively improved the appearance of nasolabial fold wrinkles for the six months of patient follow-up after the third and final treatment. How long the effect may last beyond six months is a topic of further study. In clinical trials, the most common adverse reactions were injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis, and pruritus.