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註冊 2012-5-14 用戶註冊天數 4377
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參考https://www.ft.com/content/83bb4ed0-3eed-11e7-9d56-25f963e998b2與http://www.genetinfo.com/investment/featured/item/8487.html懷疑:Genet觀點看了Financial time的報導就下了Amgen無法拿到 Evenity (romosozumab)藥證的結論。
1.根據臨床試驗的原則都是要經過1期才能到2期,最後才能到3期,而現在是在3期,3期是看療效,安全性早在1期就看了,而根據這篇報導(http://www.prnewswire.com/news-releases/amgen-and-ucb-announce-top-line-phase-3-data-from-active-comparator-study-of-evenity-romosozumab-in-postmenopausal-women-with-osteoporosis-300461160.html)3期療效皆達標,很少看到達標卻不給藥證的例子;
2.根據Financial time「Evenity reduced the chances of a person developing fractures during the trial of 7,000 postmenopausal women with osteoporosis. However, 2.5 per cent of patients suffered a serious cardiovascular event — such as a heart attack, angina episode or stroke — compared with 1.9 per cent of those taking a placebo. 」 Evenity只比安慰劑多6個百分比會造成心血管問題,更何況出處也無說明這6個百分比有無統計上意義就直接下「Amgen無法拿到 Evenity (romosozumab)藥證的結論」有點牽強;
3.Financial time的文(主觀偏否定取得藥證派)內的專家也說明Amgen之Evenity (romosozumab)仍有50%機率拿到藥證。
就以上幾點除非有更具體的報告證明Evenity 安全性有問題(但應該在臨床1期就解決的問題),否則拿到藥證應該不會太難,最多就是Evenity 不能用在心血管疾病高危險群患者,但是這個也會影響Evenity 的市場大小,反正靜觀其變。
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