Allergan plc announced earlier this month that it has received a positive opinion from the Swedish Medical Products Agency for Belkyra in treating submental fullness in adults.
Belkyra (deoxycholic acid) is marketed as Kybella in the United States. Is being evaluated through the decentralized procedure, with the Swedish Medical Products Agency acting as the reference member state for the other countries in the European Union, and Iceland and Norway, according to a press release.
Belkyra is expected to be the first non-surgical prescription medicine to be licensed in Europe for treating moderate-to-severe submental fullness in adults “when the presence of submental fat has a psychological impact on the patients,” the release reported.
“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 fell on the inside is contrary to what they see in the mirror,” David Eccleston, MB, stated in the release. “I would welcome the additional of a minimally invasive, clinically proven authorized prescription medication.”
There have been more than 20 clinical studies conducted on Belkyra with more than 2,600 patients worldwide, according to the release, including four phase 3 studies in Europe and North America, according to the release.
The clinical studies found that 63.8% of patients treated with Belkyra in the European studies and 78.5% in the North American studies achieved a 1-grade improvement in the appearance of the area under their chin 12 weeks after last treatment. There were 44.6% of patients in the European studies and 48.6% in the North American sties who reported their psychological impact was improved, compared with 18% and 17.3% of people treated with placebo, respectively, according to the release. Side effects reported were mild to moderate in severity, primarily located at treatment area, and resolved without intervention, the release reported.
“We look forward to our continued work with the EU member states, Norway and Iceland to secure marketing authorizations to make this important new treatment option available to customers and patients,” David Nicholson, chief research and development officer at Allergan, stated in the release.