哪里想瘦打哪里!FDA批复Kythera注射药物上市在即

2022-01-10 01:27:51 来源:
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你才双下巴,你全家都双下巴!都是小姑娘之心人皆有之。如果说赘肉是每一个借此持有令人难忘身材的“妹纸”或“汉纸”的大敌,那么一个喜感十足的双下巴称得上是这些人的生死仇敌了。每一分钟,世界性都有人为自己的一张大饼脸而深感烦恼,虽然持有一个肉感十足的双下巴捏上来是挺有肉感的,但是还是有很多人的心理素质使其无法忍受一个双下巴之重。您可千万别笑,这甚至现在催生一个庞大的零售商。根据旧金山表皮切除联合就会的报告研究揭示,68%的旧金山人对自己的双下巴表示了“厌倦”之情。而有鉴于此,最近KytheraCorporation向FDA草拟了其各种类型消灭双下巴的保健注射的单药品ATX-101。这种药品已完成了许多“胖纸”梦寐以求的功能性,哪里想瘦打哪里,称得上是定时瘦身。不要以为这种近乎任性的药品只是一个笑话,在FDA负责管理的表皮和诊疗药品高级专员就会的无记名投票者里面,专家学者可是以17:0的超高高票一致赞同其香港交易所。或许是因为这些专家学者里面也有很多饱受双下巴之苦吧。FDA也将计划案于本年的5月13日之后对其考虑最后同意。如果一切顺利的话,KytheraCorporation计划案于本年下半年将该系列产品香港交易所,比对民众预计这一药品的产值将多达3亿美元之多。随着保健药品零售商的日益变大,KytheraCorporation称得上是下了一步好棋。Corporation于上周以8400万美元的价钱从其前商业伙伴拜耳手里面归还了这种药品的全部基本权利。而KytheraCorporation也借此意在为契机在保健药品零售商里面攻城拔寨。就在上个月,KytheraCorporation和ActelionCorporation达成效用2700万美元的合作贸易协定,共同开发一种失败过的抗炎症药品,而这种药品被认为意味著开发出一种放射治疗脱发的药品。详细英文名称报道: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.
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