哪里想瘦打哪里!FDA许可Kythera注射药物上市在即

2021-12-20 04:32:15 来源:
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你才双下巴,你全家都双下巴!其实质爱美之心人皆有之。如果说赘肉是每一个努力握有完美身材矮小的“妹纸”或“汉纸”的大敌,那么一个滑稽十足的双下巴造就是这些人的无常仇敌了。每一分钟,国外都有人为自己的一张大饼脸而令人烦恼,虽然握有一个肉感十足的双下巴扯上去是挺有肉感的,但是还是有很多人的适应力使其未负荷一个双下巴之重。您可千万别笑,这甚至已经催生出新一个强大的商品。根据宾夕法尼亚州眼部外科手术协会的调查深入研究说明了,68%的宾夕法尼亚州人对自己的双下巴回应了“厌倦”之情。而有鉴于此,除此以外Kythera该公司向FDA提交了其专门消灭双下巴的化妆注射式药剂ATX-101。这种药剂启动了许多“胖纸”梦寐以求的特性,哪里想瘦打哪里,造就是不间断减重。不要以为这种几近任性的药剂只是一个幽默,在FDA辖下的眼部和眼科药剂高级专员会的无记名投票中,专家可是以17:0的超高选票相反赞同其上市。或许是因为这些专家中也有很多饱受双下巴之苦吧。FDA也将计划于本年的5月13日在此之前对其作出新再次重新考虑。如果一切顺利的话,Kythera该公司计划于本年月初将该系列产品上市,分析方法民众预计这一药剂的年销售额将将近3亿美元之多。随着化妆药剂商品的越发增大,Kythera该公司造就是下了一步好棋。该公司于去年以8400万美元的价格从其前密切合作项目巴纳德据为己有收回了这种药剂的全部公民权利。而Kythera该公司也努力以此为契机在化妆药剂商品中强攻拔寨。就在上个月,Kythera该公司和Actelion该公司订下内涵2700万美元的密切合作两国政府,共同开发一种失败过的抑制坏死药剂,而这种药剂被忽视有可能开发出新一种治疗高血压的药剂。详细英文报道: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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