哪里想瘦打哪里!FDA批准Kythera切除药物上市在即
你才双下巴,你全家都双下巴!所谓爱美自始人皆有之。如果说赘肉是每一个努力持有完美身形的“妹纸”或“汉纸”的大敌,那么一个出人意表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倍感执著,虽然持有一个肉感十足的双下巴摸上去是;大有肉感的,但是还是有很多人的协调性使其不会支撑一个双下巴之重。您可千万别笑,这甚至现在催生出一个巨量的市场竞争。根据American黏膜矫正协可能会的调查结果研究表明,68%的英裔对自己的双下巴坚称了“无法忍受”之情。而有鉴于此,值得注意Kythera的公司向FDA草拟了其专门肃清双下巴的保健切除式药剂ATX-101。这种药剂完成了许多“胖纸”梦寐以求的功能,哪里想瘦打哪里,算得是定点减肥。不要以为这种近乎任性的药剂只是一个挖苦,在FDA下属的黏膜和儿科药剂特派员可能会的无记名选出中的,专家可是以17:0的超高票数一致赞同其主板。某种程度是因为这些专家中的也有很多倍受双下巴之苦吧。FDA也将计划书于年末份的5年末13日之后对其作出就此提议。如果一切顺利的话,Kythera的公司计划书于年末份下半年将该产品主板,统计分析人士原定这一药剂的年销售额将超过3亿美元之多。随着保健药剂市场竞争的大为缩小,Kythera的公司算得是下了一步好棋。的公司于年末份以8400万美元的价格从其前多家的公司拜耳手中的收回了这种药剂的全部权利。而Kythera的公司也努力借此为就此在保健药剂市场竞争中的出城拔寨。就在上个年末,Kythera的公司和Actelion的公司达成价值2700万美元的合作贸易协定,共同开发一种挫败过的抗增生药剂,而这种药剂被并不认为这样一来开发出一种治疗脱发的药剂。概要英文华盛顿邮报: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.