Background Analysis: US FDA Advisory Committee to Review Kythera’s Deoxycholic Acid Injection for Reducing Chin Fat and Systemic Treatment of Resistant Atopic Dermatitis in Pediatric Patients – MAR 9, 2015 (DODAC)
The US FDA has scheduled a Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) Meeting for Monday, March 9, 2015.
During the morning session, the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug (meaning a drug that leads to the dissolution or disintegration of cells), submitted by Kythera Biopharmaceuticals (Kythera), proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental (below the chin) fat in adults. In March 2014, Kythera announced they had reacquired all rights to ATX-101 (deoxycholic acid injection) outside of the U.S. and Canada from Bayer Consumer Care AG, to which it had licensed the commercial rights for ATX-101 outside of U.S. and Canada in 2010.
During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis (a.k.a. eczema) with inadequate response to topical prescription therapy.