哪里想瘦打哪里!FDA批准Kythera注射用药上市在即

2022-01-24 01:52:41 来源:
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你才双下巴,你全家都双下巴!;也爱美之心人皆有之。如果说赘肉是每一个愿意拥有完美身材的“妹纸”或“汉纸”的大敌,那么一个喜感十足的双下巴已是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感到烦恼,虽然拥有一个肉感十足的双下巴剪刀刚才是倒是有肉感的,但是还是有很多人的能力也使其无法承受一个双下巴之重。您可千万别笑,这甚至并未显现出来一个更大的市场。根据美国面部牙科协会的调查数据深入研究表明,68%的美国人对自己的双下巴透露了“无趣”之情。而有鉴于此,早先Kythera新公司向FDA审核了其专门消灭双下巴的护肤施用结构设计口服ATX-101。这种口服进行了许多“胖纸”梦寐以求的功能,哪里想瘦打哪里,已是是定点护肤。不想以为这种却是任性的口服只是一个戏谑,在FDA下属的面部和眼科口服专员会的无记名投票中的,专家可是以17:0的超高票数一致赞同其该新公司。显然是因为这些专家中的也有很多饱受双下巴之苦吧。FDA也将原计划于今年的5月13日之前对其重新考虑最后决定。如果一切顺利的话,Kythera新公司原计划于今年下半年将该系列产品该新公司,深入研究社会大众预计这一口服的年销售额将超过3亿美元之多。随着护肤口服市场的日益增大,Kythera新公司已是是下了一步好棋。新公司于去年以8400万美元的价格从其前合作伙伴拜耳手中的发还了这种口服的全部投票权。而Kythera新公司也愿意以此为就此在护肤口服市场中的攻城拔寨。就在上个月,Kythera新公司和Actelion新公司达成价值2700万美元的合作协议,共同开发一种告终过的抗发炎口服,而这种口服被指出不太可能开发出一种治疗皮肤炎的口服。详述英文报道: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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