哪里想瘦打哪里!FDA批复Kythera注射药物上市在即

2022-01-03 03:41:17 来源:
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你才双下巴,你全家都双下巴!所谓爱美有心人皆有之。如果说赘肉是每一个希望握有理想身材的“妹纸”或“汉纸”的大敌,那么一个喜感十足的双下巴造就是这些人的无常仇敌了。每一分钟,世界各地都有人为自己的一张大饼脸而沮丧烦恼,虽然握有一个肉感十足的双下巴捏上去是才行有肉感的,但是还是有很多人的同龄使其无法承受一个双下巴之重。您可千万别疯,这甚至早就催生出一个庞大的产品。根据美国皮肤外科手术协会的调查科学研究显示,68%的美国人对自己的双下巴表示了“无趣”之情。而有鉴于此,最近Kythera日本公司向FDA提出了其专门击垮双下巴的彩妆注射式口服ATX-101。这种口服完成了许多“胖纸”梦寐以求的功能,哪里想瘦打哪里,造就是定点健美。不要以为这种近乎蛮横的口服只是一个疯话,在FDA的总部的皮肤和眼科口服专员会的无记名选出中都,医学专家可是以17:0的超高票相符赞同其上市。毫无疑问是因为这些医学专家中都也有很多饱受双下巴之苦吧。FDA也将方案于当年的5月13日之前对其跟进最后决定。如果一切顺利的话,Kythera日本公司方案于当年下半年将该产品上市,分析人士预计这一口服的年产值将超过3亿美元之多。随着彩妆口服产品的日趋减少,Kythera日本公司造就是下了一步好棋。日本公司于月内以8400万美元的价位从其前合作伙伴拜耳还给归还了这种口服的全部特权。而Kythera日本公司也希望以此为更进一步在彩妆口服产品中都攻城拔寨。就在上个月,Kythera日本公司和Actelion日本公司达成效益2700万美元的合作协定,共同开发一种失败过的抗击炎症口服,而这种口服被认为可能开发出一种治疗高血压的口服。具体英文华盛顿邮报: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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