Allergan gets positive opinion from Swedish MPA for Belkyra to treat patients with submental fullness

Belkyra, which is made of deoxycholic acid, will be made available under prescription to adults where there is a psychological impact for the patient.

When injected into subcutaneous fat, Belkyra destroys fat cells allowing them to not to store or accumulate fat. Re-treatment is not anticipated once the patient’s treatment goal is achieved.

Allergan claims that it will be the first prescription medicine to be licensed in Europe for the treatment of moderate to severe double chin.

Belkyra is being assessed via 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.

Allergan chief R&D officer David Nicholson said: "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."

Belkyra was subject to a worldwide clinical development program involving more than 20 clinical studies with over 2,600 patients globally.

In the clinical studies, clinicians evaluated 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.