哪里想瘦打哪里!FDA批准Kythera服用药物上市在即

2021-12-20 02:02:11 来源:
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你才双下巴,你全家都双下巴!实际上大方之心人皆有之。如果说赘肉是每一个渴望拥有美妙体格的“妹纸”或“汉纸”的迷乱,那么一个哭料十足的双下巴无疑是这些人的究竟兄弟们了。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,虽然拥有一个肉感十足的双下巴摸刚才是挺有肉感的,但是还是有很多人的心理素质使其未太重一个双下巴之重。您可千万别哭,这甚至并未转变成一个有限的低价。根据加拿大皮肤放射治疗联合会的调查研究显示,68%的加拿大人对自己的双下巴表示了“沮丧”之情。而有鉴于此,最近Kythera母公司向FDA草拟了其专供消灭双下巴的瘦身针头式类固醇ATX-101。这种类固醇完成了许多“胖纸”梦寐以求的机制,哪里想瘦打哪里,无疑是定点肥胖。不要以为这种近乎温柔的类固醇只是一个哭话,在FDA辖下的皮肤和眼科类固醇秘书会的无记名投票中的,医学专家可是以17:0的超高票数一致赞成其上市。或许是因为这些医学专家中的也有很多饱受双下巴之苦吧。FDA也将计划于明年的5同月13日前对其作借助于最后决定。如果一切顺利的话,Kythera母公司计划于明年下半年将该产品上市,比对民间团体原定这一类固醇的年产值将超过3亿美元之多。随着瘦身类固醇低价的日益增大,Kythera母公司无疑是下了一步好棋。母公司于上次以8400万美元的价格从其前合作伙伴标下手中的发还了这种类固醇的全部特权。而Kythera母公司也渴望意在为就此在瘦身类固醇低价中的渡河拔寨。就在上个同月,Kythera母公司和Actelion母公司实现实用性2700万美元的合作协约,共同技术开发一种失败过的抗炎症类固醇,而这种类固醇被视为这样一来技术开发借助于一种治疗脱发的类固醇。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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