哪里想瘦打哪里！FDA批准Kythera注射药物上市在即
2015-03-10 佚名 生物谷
你才双下巴，你全家都双下巴！ 所谓爱美之心人皆有之。如果说赘肉是每一个希望拥有完美身材的“妹纸”或“汉纸”的大敌，那么一个喜感十足的双下巴可谓是这些人的生死仇敌了。每一分钟，世界各地都有人为自己的一张大饼脸而感到烦恼，虽然拥有一个肉感十足的双下巴捏上去是挺有肉感的，但是还是有很多人的心理素质使其无法承受一个双下巴之重。 您可千万别笑，这甚至已经催生出一个庞大的市场。根据美国
你才双下巴，你全家都双下巴！
您可千万别笑，这甚至已经催生出一个庞大的市场。根据美国皮肤外科手术协会的调查研究显示，68%的美国人对自己的双下巴表示了“厌倦”之情。而有鉴于此，最近Kythera公司向FDA提交了其专门消灭双下巴的美容注射式药物ATX-101。
这种药物完成了许多“胖纸”梦寐以求的功能，哪里想瘦打哪里，可谓是定点减肥。不要以为这种近乎任性的药物只是一个笑话，在FDA下属的皮肤和眼科药物专家委员会的无记名投票中，专家可是以17：0的超高票数一致赞同其上市。或许是因为这些专家中也有很多饱受双下巴之苦吧。FDA也将计划于今年的5月13日之前对其作出最后决定。如果一切顺利的话，Kythera公司计划于今年下半年将该产品上市，分析人士预计这一药物的年销售额将超过3亿美元之多。
随着美容药物市场的日益增大，Kythera公司可谓是下了一步好棋。公司于去年以8400万美元的价格从其前合作伙伴拜耳手中收回了这种药物的全部权利。而Kythera公司也希望以此为契机在美容药物市场中攻城拔寨。就在上个月，Kythera公司和Actelion公司达成价值2700万美元的合作协议，共同开发一种失败过的抗炎症药物，而这种药物被认为有可能开发出一种治疗脱发的药物。
详细英文报道：
Kythera ($KYTH) won the unanimous support of an FDA advisory panel for its fat-busting injection, rolling toward approval with a first-of-its-kind treatment.
The agency's independent Dermatologic and Ophthalmic Drugs Advisory Committee voted 17-0 that the drug's benefits outweighed its risks for patients looking to reduce submental fat, or double chin. The FDA is not required to follow its panels' votes, though it most commonly does, and the agency has promised to make a final decision on the injection by May 13. If all goes according to plan, Kythera plans to launch the drug, ATX-101, in the second half of this year.
The biotech's shares have more than tripled since it pulled off a $73 million IPO in 2012, rising steadily as investors bet ATX-101 can carve out a space on the aesthetic market and potentially lure a Big Pharma acquirer. Kythera is pitching the injection as a much-needed nonsurgical option for double chin reduction, citing an American Society for Dermatologic Surgery survey that estimates 68% of Americans are "bothered" by submental fat.
Kythera regained full rights to ATX-101's potential last year, orchestrating an $84 million deal to buy out ex-partner Bayer. And the drug, a synthetic version of the fat-blasting deoxycholic acid, could bring in more than $300 million a year once approved, Leerink analyst Seamus Fernandez has said.
"This milestone demonstrates our commitment to developing first-in-class aesthetic products through a focus on scientific rigor and innovation," Kythera CEO Keith Leonard said in a statement. "At Kythera, we remain focused on investing in novel treatments that will allow aesthetic physicians to better meet the needs of their patients."
Kythera is also focused on raising some cash now that it has a likely approval ahead. The biotech filed for a $125 million offering as soon as the market closed on Monday. Its share price was down several points at the end of the day.
Beyond its top prospect, Kythera is working to build out a pipeline of aesthetic medicines. Last month, the California biotech signed a $27 million deal with Actelion ($ATLN) to get its hands on a once-failed anti-inflammatory medicine that could have a future as a treatment for hair loss.
版权声明：
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料，版权均属于梅斯医学所有。非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章，或“梅斯号”自媒体发布的文章，仅系出于传递更多信息之目的，本站仅负责审核内容合规，其内容不代表本站立场，本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。
在此留言
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料，版权均属于梅斯医学所有。非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章，或“梅斯号”自媒体发布的文章，仅系出于传递更多信息之目的，本站仅负责审核内容合规，其内容不代表本站立场，本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。
在此留言
#ERA#
22
#FDA批准#
22