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              2012年3月份FDA批準抗貧血新藥Peginesatide acetate
              2012-05-15 16:54:30 來源:不詳 瀏覽:8441

              2012年3月27日,安進(Amgen)公司終于失去了對美國抗貧血藥物市場的控制權。今天中午,FDA宣布Affymax公司藥物peginesatide審批通過。Peginesatide作為一種促紅細胞生成刺激劑(erythropoiesis-stimulating agents,ESAs)藥物,將以商品名Omontys出售。該審批為藥物Epogen的競爭對手進入市場鋪平了道路,為患者提供了一種更便利的給藥方案。Epogen是安進(Amgen)公司經久不衰的貧血癥重磅炸彈。

              Peginesatide最大的優勢在于,患者只需每月注射一次;而對于Epogen,則需每月注射多達12次。

              "Omontys是自2001年以來獲FDA批準和銷售、用于治療貧血癥的首個新藥,"FDA藥物評價及研究中心(CDER)、血液學和腫瘤產品辦公室主任Richard Pazdur醫師說道。"這種新藥物,為患者及衛生保健服務者提供了極大的便利,患者只需每月注射一次,而不是更頻繁。"

              此次獲批標志著Affymax的偉大勝利,在2010年時,Affymax不得不積極應對其心血管疾病風險來贏得監管機構的點頭。武田(Tekeda)公司也將利用Affymax分割美國的市場。

              安進(Amgen)公司一直在積極維護自己在貧血癥藥物市場中的地位,其產品Epogen獨家供應給合作伙伴DaVita公司長達7年之久。有分析師預測,Peginesatide每年將為Affymax公司帶來7億美元的銷售額,其中大部分來自于Epogen特權經營的重新定位。

              Peginesatide acetate

              別名:Poly(oxy-1,2-ethanediyl), α-hydro-ω-methoxy-, diester with 21N6,21'N6-[[(N2,N6-dicarboxy-L-lysyl-β-alanyl)imino]bis(1-oxo-2,1-ethanediyl)]bis[N-acetylglycylglycyl-L-leucyl-L-tyrosyl-L-alanyl-L-cysteinyl-L-histidyl-L-methionylglycyl-L-prolyl-L-isoleucyl-L- threonyl-3-(1-naphthalenyl)-L-alanyl-L-valyl-L-cysteinyl-L-glutaminyl-L-prolyl-L-leucyl-L-arginyl-N-methylglycyl-L-lysinamide] cyclic (6→15),(6'→15')-bis(disulfide), acetate (salt); N6.21,N6.21'-{[(N2,N6-bis{[ω-methoxypoly(oxyethylene)]carbonyl}-L-lysyl-β- alanyl)imino]bis(methylenecarbonyl)}bis[acetylglycylglycyl-L-leucyl-L-tyrosyl-L-alanyl-L- cysteinyl-L-histidyl-L-methionylglycyl-L-prolyl-L-isoleucyl-L-threonyl-3-(naphthalen-1-yl)- L-alanyl-L-valyl-L-cysteinyl-L-glutaminyl-L-prolyl-L-leucyl-L-argin

              CAS號:1185870-58-9


              分子式:C231H350N62O58S6[C2H4O]n.2C2H4O

               

               

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