U.S. FDA approves Allergan’s CoolSculpting fat-freezing system for removal of fat below the jawline.
Medical aesthetics is a key area for Allergan and has been since the company acquired Botox maker Actavis. Since the company is currently looking for buyers for its infectious disease and women’s health businesses, it seems that medical aesthetics will be even more of a focus for Allergan going forward. In fact, the company plans to double revenue from the medical aesthetics business to $7–8 billion by 2025.
With Botox facing challenges from a number of new competitors, reaching that goal will require garnering additional approvals in new indications for its CoolSculpting fat-freezing system. Allergan made a positive step in that direction this October with the approval by the U.S. Food and Drug Administration (FDA) of the body contouring treatment for reducing fat below the jawline.
This approval is the first by the FDA for a nonsurgical fat reduction system intended to contour the submandibular area. The approval was based on results of a 22-week clinical trial, which indicated that, after two treatments, recipients experience a one-third reduction in fat layer thickness.
CoolSculpting now has nine FDA approvals, including for the reduction of bra fat, back fat, thigh fat, abdomen fat and others. According to Allergan, CoolSculpting has been used by doctors 7 million times since it received its first approval. The company expects the use rate to increase as more indications are approved and sales to eventually pass $1 billion annually. Some additional indications being pursued by Allergan include muscle contouring, skin tightening and indications related to cellulite.