Allergan plc last week received a positive opinion
from the Swedish Medical Products Agency (MPA) for BELKYRA (deoxycholic acid), which can now be licensed in Europe to treat submental fat, or double
"We are delighted to receive the Positive Opinion from the Swedish Medical Products Agency (MPA) for BELKYRA, which provides men and women who are bothered by submental fullness with a new minimally invasive treatment option," David Nicholson, Chief R&D Officer at Allergen, said. "Because of the extensive evidence behind the product, we see BELKYRA as a breakthrough treatment that will complement other aesthetic treatments. "
Double chin is a troublesome condition for many patients. The American Society for Dermatologic Surgery (ASDS) reports that 67 percent of patients are concerned about the excess fat under the chin and neck. The condition is not limited to overweight patients; it occurs in every body type.
"In my practice, I see many patients – both men and women – whose self-esteem has been negatively impacted by fullness under their chin; often the way they feel on the inside is contrary to what they see when they look in the mirror," Leading Cosmetic Physician David Eccleston said.
More than 20 clinical trials have been conducted on BELKYRA, including four Phase III studies. The two trials in Europe and two in North American resulted in 63.8 and 78.5 percent of the participants finding a 1-grade improvement under their chins. The treatments also improved the participants' psychological state, at a rate of 44.6 percent and 48.6 percent, respectively.
"Once approved, BELKYRA will provide a complementary fit to our broader medical aesthetics portfolio. We are looking forward to bringing the product to market and training physicians on how to best use this new treatment," Allergan International President Paul Navarre said.