哪里想瘦打哪里!FDA核准Kythera注射药物上市在即

2022-01-31 03:47:03 来源:
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你才双下巴,你全家人都双下巴!所谓爱美意欲人皆有之。如果说赘肉是每一个渴望拥有令人难忘身材的“妹纸”或“汉纸”的大敌,那么一个喜感十足的双下巴更是是这些人的世间不信了。每一分钟,世界各地都有人为自己的一张大饼脸而感到疑惑,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身体素质使其不能承受一个双下巴之重。您可千万别笑,这甚至仍未催生出一个远超过的消费市场。根据美国皮肤手术协不会的调查研究成果显示,68%的美国人对自己的双下巴坚称了“沮丧”之情。而有鉴于此,已经有Kythera该公司向FDA提出了其都由打倒双下巴的保健注射样式药剂ATX-101。这种药剂顺利完成了许多“胖纸”梦寐以求的功能,哪里想瘦打哪里,更是是确保安全减肥。绝不会以为这种几乎蛮横的药剂只是一个玩笑,在FDA下属的皮肤和眼科药剂专员不会的无记名投票选举里,研究者可是以17:0的超高票数明确异议其主板。某种程度是因为这些研究者里也有很多饱受双下巴之苦吧。FDA也将方案于今年的5月13日之前对其这两项最后提议。如果一切顺利的话,Kythera该公司方案于今年下半年将该新产品主板,分析民间团体预计这一药剂的年销售额将超过3亿美元之多。随着保健药剂消费市场的日趋增大,Kythera该公司更是是下了一步好棋。该公司于去年以8400万美元的价格比从其前商业伙伴巴纳德控制权返还了这种药剂的全部权利。而Kythera该公司也渴望更进一步为伊始在保健药剂消费市场里攻城拔寨。就在上个月,Kythera该公司和Actelion该公司达成价值2700万美元的密切合作协议,密切密切合作一种失败过的效增生药剂,而这种药剂被认为也许共同开发出一种治疗脱发的药剂。详细英文引述: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.
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