Fibrocell Science announced that the FDA has approved laVív (azficel-T) for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. This approval was based on data from the combined results of two identical Phase 3 multicenter, randomized, double-blind, placebo-controlled studies of 421 patients that showed that 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 six months of patient follow-up after the third and final treatment.
laVív is an individualized treatment that is made from the patient’s own fibroblast cells, which are responsible for collagen production. Small fibroblast samples are taken from behind the patient’s ear and sent to the Fibrocell Science lab. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment.
For more information call (484) 713-6000 or visit www.fibrocellscience.com.