Part of Allergan’s medical aesthetics strategy depends on securing follow-on indications for its CoolSculpting fat-freezing system, and the product recently came through with a new approval.
The FDA greenlighted the body contouring treatment to combat fat below the jawline, making it the first nonsurgical fat reduction system with a go-ahead to contour that area. Regulators based their decision on a 22-week clinical study that showed an average 33% reduction in fat layer thickness after two treatments, Allergan said.
The blessing gives CoolSculpting, which Allergan says doctors have already used 7 million times since its hit the scene, 9 FDA approvals. The below-the-jaw clearance joins a list that includes OKs for bra fat, back fat, thigh fat, abdomen fat and more.
"This new indication to treat the submandibular area underscores Allergan's dedication to research and innovation within the body contouring category," Allergan R&D chief David Nicholson said in a statement.
Allergan isn’t stopping there, though. As it last month laid out as part of its medical aesthetics day, it’s expecting to double revenue from that business by 2025 to between $7 billion and $8 billion—and CoolSculpting has a big role to play in making that happen, particularly with challengers chasing down lead drug Botox.
The company expects the fat-fighter’s growth to speed up, helping it surpass $1 billion in annual global sales by that same year. And new FDA nods will be key to the expansion; the company is eyeing muscle contouring, skin tightening and indications related to cellulite as avenues for growth.
While medical aesthetics has always been a core area for Allergan—at least, since the company once called Actavis bought the Botox maker and adopted its name—these days, it’s looking especially key. In response to investor pressure, the company has put its infectious disease and women’s health units up for sale to double down in the area.