Allergan (AGN) Announces Receipt of Marketing Approval in Sweden for BELKYRA as Double Chin Treatment

October 13, 2016 7:05 AM EDT

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Allergan plc (NYSE: AGN) announced that Sweden has received the Marketing Authorisation for BELKYRA (deoxycholic acid) after being granted approval by the Swedish Medical Products Agency (MPA). BELKYRA is a prescription medicine for the treatment of moderate-to-severe convexity or fullness associated with submental fat (often called double chin) in adults when the presence of submental fat has a psychological impact for the patient.3 Fullness under the chin can impact how a person feels about themselves and, for both women and men, can lead to feelings of negative self-impression.4

"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 United States 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 3 clinical studies involving more than 2,600 patients worldwide.5 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.6 When injected into fat under the chin, BELKYRA® permanently causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.1

Fullness under the chin (or double chin) is a concern for many people. In fact, according to data from the American Society for Dermatologic Surgery (ASDS) in 2015, fat under the chin/neck was one of the top troublesome conditions for patients, with 67% reporting being concerned or bothered about the condition.3 This is similar in number to the percentage of people who are bothered by lines and wrinkles.3 There is a common misperception that fullness under the chin only appears in those who are overweight, when in reality it can occur in any body type and may be related to ageing, genetics or weight gain.7

"In my practice, I see many patients – both women and men – who were bothered by their double chin but who were reluctant to undergo surgery," said Shannon Humphrey, Cosmetic Dermatologist at Carruthers & Humphrey Cosmetic Dermatology, Vancouver, Canada and BELKYRA® Clinical Investigator. "In the few months since BELKYRA® was approved by Health Canada, many of my current patients have started treatment, and it's also opened a door for patients who have never seen an aesthetic practitioner before but who are concerned about their double chin. BELKYRA® has been a valuable addition to my treatment portfolio, as I can offer patients new ways to achieve the results they desire."

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.3 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.3

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.3 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.3 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.8

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.

BELKYRA® was evaluated through a Decentralised Procedure, with the Swedish agency (MPA) acting as the Reference Member State and included 20 other countries in the European Union, as well as Iceland and Norway. Allergan will continue to work with other health regulatory agencies around the world to bring this valuable treatment option to people with fullness under the chin. BELKYRA® is already licensed in Canada, Australia, Iceland, Hungary, Austria, Lithuania, Estonia, Latvia, Romania, Bulgaria and Norway, as well as in the U.S. as KYBELLA®.

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