There’s a big story in cosmetic health care today.
A Food and Drug Administration panel has voted — unanimously — to recommend approval of a double chin-reducing injectable drug, the The Wall Street Journal reports.
Here’s how the company puts it:
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) announced today that the U.S. Food and Drug Administration’s (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults, which is often referred to as a double chin…
Investors have generally been excited about the drug: though shares in developer Kythera Biopharmaceuticals are down by around 1.5% since the announcement, they are up nearly 60 per cent since talk of the drug started to emerge last summer.
“We are pleased that the FDA advisory committee recognised the importance of providing patients with a clinically-proven treatment option specifically developed to contour submental fullness, a much-cited yet undertreated facial aesthetic complaint,” chief medical officer Frederick C. Beddingfield.
The could launch as soon as later this year.
One analyst cited by the Journal expects sales of the drug, dubbed ATX-101, to raise upward of $US300 million annually. That would be good news for Kythera, which recently reported a $US135 million loss for 2014. They’re planning a $US125 million share offering to develop the drug if it’s approved, the Journal reported.