Allergan plc, a leading global pharmaceutical company, has received a positive opinion from the Swedish Medical Products Agency (MPA) for Belkyra (deoxycholic acid).
Belkyra will be the first prescription medicine to be licensed in Europe 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.
Belkyra is being evaluated through the Decentralised Procedure, with the Swedish MPA acting as the Reference Member State for 20 other countries in the European Union, as well as Iceland and Norway.
"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," said David Nicholson, chief R&D officer at Allergan. "Because of the extensive evidence behind the product, we see Belkyra as a breakthrough treatment that will complement other aesthetic treatments. We look forward to our continued work with the 20 EU member states, Norway and Iceland to secure marketing authorizations to make this important new treatment option available to customers and patients."
Submental fullness (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 topped the list of most troublesome conditions for patients, with 67% reporting being concerned or bothered about the condition. 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 aging, genetics or weight gain.
"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," said Leading Cosmetic Physician David Eccleston. "I would welcome the addition of a minimally invasive, clinically proven, authorized prescription medicine that meets Good Manufacturing Practice Standards to my practice, and it would give me confidence to be able to offer an effective and proven solution for double chin (submental fullness) to my patients."
"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," said Paul Navarre, president, Allergan International.
Belkyra has been the focus of a global clinical development programme involving over 20 clinical studies with more than 2,600 patients worldwide. Four phase III clinical studies have assessed the efficacy and safety of Belkyra in adults with moderate to severe fullness under the chin; two in the US and two in Europe. In the clinical studies, clinicians assessed that 63.8% of people treated with Belkyra in the European studies and 78.5% of patients in the North America studies achieved a 1-grade improvement in the appearance of the area beneath their chin at 12 weeks after their last treatment. 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 their submental fullness (compared with 18% and 17.3% of people treated with placebo, respectively) during the same time period.1 Belkyra was generally well tolerated. Most side effects were mild or moderate in severity, primarily associated with the treatment area and resolved without intervention.
As a next step, Allergan will work to secure the national Marketing Authorisations in the Concerned Member States. Once the national licenses have been granted, Allergan will begin to train healthcare professional customers on the safe and effective use of this new treatment. Allergan is already working with other health regulatory agencies around the world to bring this valuable treatment option to people with submental fullness. Belkyra is already licensed in Canada, as well as in the US as Kybella.
A double chin is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearance – frequently leading to an older and heavier look. Submental fullness can affect adults – both women and men – of all ages, weight and gender. Influenced by multiple factors including aging and genetics, submental fullness is often resistant to diet and exercise. Submental fullness is the result of aging on the foundation of the skin, muscle, bone and fat.
For Belkyra, Sweden serves as the Reference Member State in the Decentralised Procedure. The other 22 Concerned Member States are Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovenia, Slovakia and Spain. Allergan expects to finalise the Marketing Authorisations and launch the product in most of these countries in the latter half of 2016 or early 2017.
Belkyra contains a non-human, non-animal version of deoxycholic acid which is identical to naturally-occurring deoxycholic acid. When injected into subcutaneous fat, Belkyra causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat, so re-treatment is not expected once the patient's treatment goal is achieved.