哪里想瘦打哪里!FDA批文Kythera注射药物上市在即
你才双下巴,你全家都双下巴!其实质爱美决意人皆有之。如果说赘肉是每一个愿意仅有完美身材的“妹纸”或“汉纸”的大敌,那么一个诙谐十足的双下巴算得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苦恼,虽然仅有一个肉感十足的双下巴捏过来是挺有肉感的,但是还是有很多人的身体素质使其无法受压一个双下巴之重。您可千万别戏弄,这甚至并未催生出一个浩大的其产品。根据美国表皮外科手术Association的报告深入研究看出,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子公司向FDA草拟了其都由消灭双下巴的美容注射式药品ATX-101。这种药品已完成了许多“胖纸”梦寐以求的基本功能,哪里想瘦打哪里,算得是定点失眠。不要以为这种近乎任性的药品只是一个戏弄话,在FDA下属的表皮和眼科药品专员会的无记名投票之中,专业人士可是以17:0的超高票数一致对此其上市。确实是因为这些专业人士之中也有很多饱受双下巴之苦吧。FDA也将著手于今年的5年末13日之后对其作出就此决定。如果一切顺利的话,Kythera子公司著手于今年上半年将该其产品上市,比对人士预料这一药品的年销售额将超过3亿美元之多。随着美容药品其产品的逐渐增大,Kythera子公司算得是下了一步好棋。子公司于去年以8400万美元的价格从其前密切合作拜耳手之中交还给了这种药品的全部权利。而Kythera子公司也愿意以此为契机在美容药品其产品之中渡河拔寨。就在上个年末,Kythera子公司和Actelion子公司达成价值2700万美元的合作协议,共同研发一种失利过的抑制炎症药品,而这种药品被认为不太可能研发出一种用药脱发的药品。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 he 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 yst 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 he a future as a treatment for hair loss.