FDA reviewers took no issue with Kythera Biopharmaceuticals' ($KYTH) drug to reduce chin fat, signing off on its efficacy ahead of a crucial panel meeting.
In documents released ahead of next week's Dermatologic and Ophthalmic Drugs Advisory Committee meeting, agency staff concluded that the drug, ATX-101, had benefits that outweighed its risks, besting placebo in shrinking double chins and charting an "improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults."
On March 9, the independent committee will meet to discuss ATX-101's merits, handing down a nonbinding vote on whether it should be approved. The FDA, which usually follows its committees' recommendations, is scheduled to issue a final decision by May 13.
Kythera is the sole owner of ATX-101's potential, orchestrating an $84 million deal last year to regain the drug's global rights from ex-partner Bayer. And the drug, a synthetic version of the fat-busting deoxycholic acid, could bring in more than $300 million a year once approved, Leerink analyst Seamus Fernandez has said.
ATX-101's progress at the FDA sent Kythera's shares up more than 25% on Thursday. And, thanks largely to the drug, the company's stock price has more than tripled since its 2012 IPO.
Beyond its top prospect, Kythera is working to build out a pipeline of aesthetic medicines. Last month, the California biotech signed a $27 million deal with Actelion to get its hands on a once-failed anti-inflammatory medicine that could have a future as a treatment for hair loss.
- read the briefing (PDF)