Results Wire: US FDA Advisory Committee Unanimously Supports Kythera’s Deoxycholic Acid Injection for Reducing Chin Fat and Earlier Development of Systemic Treatments for Resistant Atopic Dermatitis in Pediatric Patients – MAR 9, 2015 (DODAC)
On Monday, March 9, 2015, in the morning session, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously supported, by a vote of 17-Yes to 0-No, the safety and efficacy of Kythera Biopharmaceutical’s deoxycholic acid injection for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental (below the chin) fat in adults.
In the afternoon session, the DODAC discussed systemic treatment of resistant atopic dermatitis in pediatric patients. In general, the Committee supported an “early as possible” approach to the development of drugs to treat pediatric patients with moderate to severe disease who have been resistant to available therapies.