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Fibrocell Science (OTCBB: FCSC.OB), FDA approves BLA for laViv, personalized aesthetic cell therapy

laVív® (azficel-T) 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, laVív was well tolerated with the majority of adverse events being injection-site reactions that were of mild to moderate intensity and resolved within 1 week;
  • The patented technology behind laVív is an advanced process that extracts and multiplies a specific kind of a person’s own skin cells (fibroblasts) to create laVív, which is then injected into the patient to improve the appearance of smile lines;
  • In normal skin, fibroblasts are responsible for producing collagen.

The Bottom Line: The FDA approval was based in part on the combined results of 2 identical P3 multi-center, randomized, double-blind, placebo-controlled studies of 421 patients. Treatment was administered in three sessions approximately 5 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. Based on these trials, laVív effectively improved the appearance of nasolabial fold wrinkles for the 6 months of patient follow-up after the third and final treatment. How long the effect may last beyond 6 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. To fulfill a post marketing requirement, and as part of on-going commitment to patients, Fibrocell will establish a registry of approximately 2,700 patients to further evaluate the safety of this autologous cell therapy.