The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.
The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.
The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.
LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.
Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.
Additional information about LaVív is available at www.mylaviv.com.