FDA staff backs Kythera’s injection to reduce double chin



(Reuters) – Kythera Biopharmaceuticals Inc’s injection for “double chin” reduction was backed by U.S. Food and Drug Administration staff, who concluded the drug’s benefits outweighed its risks.

Kythera’s stock jumped 22.5 percent to $48.87 and was one of the top percentage gainers on the Nasdaq on Thursday.

The drug, ATX-101, is a formulation of deoxycholic acid, and is designed to work as a less-invasive, non-surgical option to reduce “submental fullness”.

Independent experts are scheduled to meet on Monday to discuss the drug and recommend whether it should be approved.

The agency is slated to make its final decision on the drug by May 13.

Leerink Partners analyst Seamus Fernandez said he expects the injection to be approved in May.

(Reporting by Natalie Grover in Bengaluru)