June, 2011 Fibrocell Science Press Release —
Fibrocell Science, Inc., a cell therapy company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today that the U.S. Food and Drug Administration (FDA) approved the Company’s lead product, laVív (azficel-T). laVív 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. The injection-site reactions were of mild to moderate intensity and can be resolved within one week.
How does laViv work?
The patented technology, called laVív, is an advanced process that extracts and multiplies skin cells known as fibroblasts. In normal skin, fibroblasts are responsible for producing collagen. The loss of collagen causes skin to sag and droop. The patented technology creates laVív, which is then injected into that patient to improve the appearance of nasolabial fold wrinkles, or smile lines.
“The concept of using a patient’s own collagen-making cells is a revolutionary way to help treat nasolabial fold wrinkles and help restore a fresh appearance,” said Dr. Robert A. Weiss, clinical associate professor at Johns Hopkins School of Medicine and director of the Maryland Laser Skin & Vein Institute, and an investigator for the laVív clinical trials. “Since this is a biological process that works over time, laVív is able to provide gradual and natural-looking results.”
When And Where Will laViv be First Available?
According to Fibrocell, laVív will be available beginning in July in select markets where the clinical investigators are located, including New York, Los Angeles, San Diego, Miami and other major metropolitan areas. Initially, Fibrocell will offer certified training to dermatologists and plastic surgeons. Fibrocell will do it own marketing in the U.S. Outside the U.S., the company plans to pursue partnerships to market the product. The company is not pursuing foreign markets at this time
Efficacy Studies
The combined results of two identical phase III studies of 421 patients showed laVív 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 still being studied.
Safety Studies
LaVív was well tolerated in the clinical studies with the majority of adverse events being mild to moderate injection-site reactions. Fibrocell also said it will establish a registry of about 2,700 patients to further evaluate the safety of the cell therapy to fulfill a post marketing requirement for the drug.