Allergan's Belkyra receives marketing authorisation in Sweden

Marketing authorization given for the treatment of moderate to severe fullness under the chin.

"Belkyra provides physicians with one of the first clinically evaluated and approved treatments for their patients who are bothered by fullness under the chin. We are very excited to receive the marketing authorisation for Belkyra in Sweden and we are expecting more countries to follow in the next months," said Bill Meury, Chief Commercial Officer, Allergan. "We believe Belkyra will be a breakthrough treatment in Europe, as it has been in the US and Canada, and it complements our established medical aesthetics portfolio. We look forward to introducing Belkyra to other countries around Europe over the coming months, as we secure the additional national approvals."

Belkyra is the only non-surgical injectable treatment for reduction of fullness under the chin that has undergone rigorous clinical evaluation, including four Phase III clinical studies involving more than 2,600 patients worldwide. Until now, treatment options for submental fullness have been limited to surgical options such as liposuction and non-surgical in-clinic procedures using handheld devices or aggressive weight-loss regimens with potentially limited improvement. When injected into fat under the chin, Belkyra permanently causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.

Treatment with Belkyra takes place in-clinic by a trained medical aesthetic physician. Many people experience improvement after two to four treatment sessions spaced at least 4 weeks apart. A maximum of six treatments may be given. A patient's physician will carry out a full facial assessment to help them determine how many treatment sessions they may need based on the amount and distribution of the fat under their chin and their personal treatment goals.

Four Phase III clinical studies have evaluated the efficacy and safety of Belkyra in adults with moderate-to-severe fullness under the chin; two in North America and two in Europe. In these studies, Belkyra was shown to have a high overall efficacy rate, demonstrated by a 1-grade improvement in fullness under the chin as assessed by the clinician in the study at 12 weeks after the last treatment (63.8% in European studies and 78.5% in the North American studies, respectively). Importantly, 44.6% of people treated with Belkyra in the European studies and 48.6% in the North American studies reported improvement in the psychological impact due to the fullness under their chin (compared with 18% and 17.3% of people treated with placebo, respectively) during the same time period. In the clinical studies, Belkyra was generally well tolerated. Most side effects (including injection site pain/swelling and bruising) were mild or moderate in severity, primarily associated with the treatment area and resolved without intervention.

As a next step, Allergan will begin to train appropriate healthcare professionals on the safe and effective use of this new treatment to ensure optimal patient satisfaction and outcomes.