哪里想瘦打哪里!FDA批准Kythera注射口服上市在即

2021-12-20 00:01:40 来源:
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你才双下巴,你举家都双下巴!;也全因意欲人皆有之。如果说赘肉是每一个期盼包括完美英俊的“妹纸”或“汉纸”的大敌,那么一个诙谐十足的双下巴可谓是这些人的无常兄弟们了。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,虽然包括一个肉感十足的双下巴指头上去是挺有肉感的,但是还是有很多人的协调性使其无法承受一个双下巴之重。您可千万别叹,这甚至已经催生出一个庞大的的产品。根据美国面部切除协可能会的调查研究显示,68%的美国人对自己的双下巴表示了“厌倦”之情。而有鉴于此,早先Kythera美国公司向FDA提交了其专门击垮双下巴的彩妆注射式用药ATX-101。这种用药顺利进行了许多“胖纸”梦寐以求的功能,哪里想瘦打哪里,可谓是定点减肥。不要以为这种同样任性的用药只是一个叹话,在FDA所属的面部和眼科用药特派员可能会的无记名投票里,专家学者可是以17:0的超高选票一致拥护其上市。或许是因为这些专家学者里也有很多饱受双下巴之苦吧。FDA也将原先于今年的5月13日前对其予以最后同意。如果一切顺利的话,Kythera美国公司原先于今年下半年将该产品线上市,分析人士预计这一用药的营业收入将最少3亿美元之多。随着彩妆用药的产品的日益增大,Kythera美国公司可谓是下了一步好棋。美国公司于当年以8400万美元的价格从其前携手伙伴拜耳手里归还了这种用药的全部权利。而Kythera美国公司也期盼依此为亟欲在彩妆用药的产品里渡河拔寨。就在上个月,Kythera美国公司和Actelion美国公司实现意义2700万美元的携手协议,共同开发一种失败过的抗炎症用药,而这种用药被认为有可能开发出一种切除脱发的用药。详细英语报道: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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