Stock Jumps as FDA Staff Backs Kythera's Double Chin Injection
Published: Mar 09, 2015
March 6, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration (FDA) has determined that an injection designed to reduce “double chin” from Kythera Biopharmaceuticals has benefits that outweigh its risks. Since the announcement of this news on March 5, stock prices of California-based biopharmaceutical company have jumped about 25 percent.
The drug, known as ATX-101, is a formulation of deoxycholic acid. It can destroy fat cells under the chin but leave surrounding tissue unaffected, according to Reuters. Current options for “double chin” are limited to surgery performed under general anesthesia. The FDA determined that ATX-101 has a generally positive safety profile.
“The safety evaluation program for ATX-101 was comprehensive,” the FDA wrote in its report. “It included both spontaneously reported and elicited AEs, acute and late-onset events, ECGs, and clinical laboratory evaluations. Particular attention was also given to a large set of special interest AEs that might be expected to occur given the mode of administration (injection), mechanism of drug action, or the resulting tissue response.”
Canadian and Swiss drug regulators are now also reviewing ATX-101 as a potential treatment.
Introducing ATX-101 to Australia
Kythera Biopharmaceuticals announced on Feb. 4 that it had submitted ATX-101 as a first-in-class “double chin” treatment to Australia’s Therapeutic Goods Administration.
Its presentation to the regulatory group included data from two Phase III trial, REFINE-1 and REFINE-2. The research showed that ATX-101 could visibly reduce the amount of fat under the chin and provide a significant visual improvement.
“Kythera is committed to making ATX-101 available in key markets to treat submental fullness, an often-cited yet under-addressed condition that can occur regardless of a person’s weight,” said Keith Leonard, president and chief executive officer of Kythera Biopharmaceuticals. “We plan additional submissions to regulatory authorities in other countries during the remainder of this year.”
ATX-101 is currently in late-stage clinical development. If it is approved, it will be a less-invasive, non-surgical option for individuals who are living with submental fullness, also known as “double chin.” ATX-101 has been in development for more than eight years, and it has been featured in 19 clinical studies involving 2,600 patients.
Kythera maintains active research in pigmentation modulation, facial contouring, and hair and fat biology. The company was originally founded founded in 2005, and it continues to focus on the aesthetic medicine market.
BioSpace Temperature Poll
Last week controversy erupted over the compensation package for Sanofi’s new CEO, Olivier Brandicourt, with several French government officials decrying the amount, calling it "incomprehensible." Brandicourt could walk off with as much as $4.5 million in a “golden handshake” payment in addition to making $4.76 million a year. That base figure is comprised by a fixed annual salary of $1.36 million a year, which is supplemented by a performance-related bonus of between 150 to 250 percent, as well as stock options and performance shares.
So BioSpace wants your opinion, what do you think?