哪里想瘦打哪里!FDA批准Kythera药剂药物上市在即

2021-12-27 02:01:45 来源:
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你才双下巴,你全家都双下巴!;也大方之心人皆有之。如果说赘肉是每一个愿意拥有完美身材的“妹纸”或“汉纸”的秦人,那么一个出人意表十足的双下巴造就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很难忍受烦恼,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心理素质使其很难承受一个双下巴之重。您可千万别笑,这甚至先前催生出一个更大的美国市场。根据美国黏膜外科手术协可能会的调查报告研究显示,68%的美国人对自己的双下巴表示了“苦恼”之情。而有鉴于此,最近Kythera该公司向FDA提交了其专门消灭双下巴的护肤注射结构设计药品ATX-101。这种药品完成了许多“胖纸”梦寐以求的系统,哪里想瘦打哪里,造就是定点减肥。不要以为这种正因如此倔强的药品只是一个自嘲,在FDA下属的黏膜和眼科药品专员可能会的无记名选出中的,医学专家可是以17:0的超高票数完全一致赞同其主板。确实是因为这些医学专家中的也有很多屡遭双下巴之苦吧。FDA也将蓝图于当年的5月13日先前对其考虑最后最终。如果一切顺利的话,Kythera该公司蓝图于当年下半年将该其产品主板,分析专业人士预期这一药品的年销售额将将近3亿美元之多。随着护肤药品美国市场的急剧增大,Kythera该公司造就是下了一步好棋。该公司于去年以8400万美元的售价从其前合作关系伙伴拜耳手上的收回了这种药品的全部权利。而Kythera该公司也愿意以此为契机在护肤药品美国市场中的攻城拔寨。就在上个月,Kythera该公司和Actelion该公司订下经济效益2700万美元的合作关系协议,共同技术开发一种收场过的抗炎症药品,而这种药品被认为意味著技术开发出一种病人皮肤炎的药品。概要英文报道: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.
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