Kythera investors received some good news today after it emerged that US regulatory advisors are backing approval of the firm’s treatment for double chin.
The US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support marketing clearance for ATX-101 injection, a formulation of a purified synthetic version of deoxycholic acid, for improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults.
If approved, ATX-101 would be a first-in-class submental contouring injectable drug, addressing “a much-cited yet undertreated facial aesthetic complaint”, the firm noted.
In March last year Bayer said it was handing back the non-North Amercian rights to the drug to Kythera. “While we believe ATX-101 will fulfil an unmet global need, Bayer's strategic focus has evolved" since it licensed the drug in 2010, Erica Mann, head of its consumer care division, said at the time.