June 23, 2011
FDA Approves New Treatment For Laugh Lines
Regulators from the Food and Drug Administration (FDA) have approved a new therapy utilizing a person's own skin cells to create an injectable cosmetic plumper to smooth out laugh lines, AFP is reporting.
Pennsylvania-based Fibrocell Science has been approved a license to market laViv, which multiplies a person's own collagen cells and creates an injectable cosmetic. "laViv 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 in adults," a company statement said.
"In clinical trials, laViv 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 drug will compete with Allergan Inc.'s Botox, a toxic injection that relaxes facial muscles, and wrinkle fillers such as Allergan's Juvederm and Medicis Pharmaceutical Corp. (MRX)'s Restylane which uses animal collagens or chemicals, Bloomberg reports.
"The concept of using a patient's own collagen-making cells is a revolutionary way" to help reduce the creases that extend from the sides of the nose to the corners of the mouth," Robert Weiss, a clinical associate professor at Johns Hopkins School of Medicine in Baltimore, and an investigator in the drug's clinical trials, said in the company statement.
Doctors take a sample of cells from behind a patient's ear and send those cells to a lab where scientists replicate hundreds of millions of fibroblasts and freeze them until they are needed for treatment, a process that takes about 90 days.
These new cells are then injected into the wrinkle site, where they produce collagen and elastin to add strength and support to the skin. Late-stage clinical trials showed the drug, administered in three sessions about five weeks apart, reduced the appearance of wrinkles for six months after the third treatment.
Fifty-seven percent of patients undergoing the laViv treatment in one study, saw an improvement. Only 30 percent who received the placebo treatment responded with similar acknowledgements, according to a summary of the research published by the New York Times.
In another study, 45 percent of patients receiving laViv thought they looked better afterward, compared to 18 percent in the control group. Doctors' opinions were more reserved, with 33 percent in the first trial and 19 percent in the second trial saying they saw an improvement in their patients from laViv, the report said.
The medicine's effectiveness after six months is "a topic of further study," the company reports. Fibrocell also is testing laViv as a treatment for acne scars, burn scars and periodontal disease, according to the company's website.
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