Allergan says its double chin correction therapy Belkyra gets positive opinion from Swedish regulators
pharmafile | July 4, 2016 | News story | Research and Development, Sales and Marketing |Â Â Allergan, Belkyra, Botox, EU, Sweden, double chin, drug trialÂ
Botox maker Allergan (NYSE: AGN) said it has received a positive opinion from the Swedish Medical Products Agency for its Belkyra (deoxycholic acid) a treatment for double chin.
The therapy 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.
David Nicholson, chief R&D officer at Allergan, 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.”
Submental fullness or double chin is a concern for many people. Fat under the chin/neck topped the list of most troublesome conditions for patients, with 67% reporting being concerned or bothered about the condition, according to data from the American Society for Dermatologic Surgery (ASDS) in 2015.
Paul Navarre, president, Allergan International, said: “Once approved, Belkyra will provide a complementary fit to our broader medical aesthetics portfolio.”
The therapy, 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.
The Dublin-based drug company’s portfolio includes wrinkle-eraser Botox and eyelash plumper Latisse. For the fourth quarter the company reported a 43% jump in revenue from Botox to $655.7 million.
Botox represented 16% of the company’s top line in the fourth quarter.
Anjali Shukla
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