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                您當前位置:網站首頁 >> 醫藥新聞 >> 醫藥行情 >> 2019年上市重磅藥物TOP10預測,罕見病藥物仍是最大贏家
               
               
              2019年上市重磅藥物TOP10預測,罕見病藥物仍是最大贏家
              2019-01-22 08:55:27 來源:搜狐 瀏覽:4381

              文 / 周亦川 編 / 袁月

              【搜狐健康】據Evaluate網站報道,各大生物制藥公司每年的新產品都會受到廣泛矚目,而亞力兄制藥的Soliris(依庫珠單抗)后續產品Ultomiris則被分析師預測為2019年最重磅的產品。這是一款用于治療成人陣發性睡眠性血紅蛋白尿癥(PNH,一種罕見血液病)的注射液,在2018年12月已獲得FDA批準,公司將專注于這款藥品的推廣,預計將在2024年達到34億美元的銷售額。

              與此同時,由于政府關門FDA的新藥審查大幅放緩,關于藥品審查的任何信息均受到了艾伯維、諾華、強生等公司的密切關注,所有人都希望在2019年初看到新產品上市的綠燈。而對于最近才提交申請的公司來說,審查推遲的嚴重性還不清楚。

              下圖是綜合EvaluatePharma以及各銷售方今年主要市場推出產品的預測,(注:PDUFA時間為藥物開發商支付FDA額外費用,加快藥物審批速度,PDUFA時間就是一個截止時間,在此時間前FDA必須對報批藥物給與審評意見,如通過,不通過,補充內容再考慮是否通過)

              如文首所說,Ultomiris將是2019年最受關注的罕見病藥物,第五位的Kala公司推出的眼科術后炎癥和疼痛的治療產品Inveltys也將達到良好的銷售額;但是,這家公司市值僅為2.15億美元,因此投資者顯然不太樂觀。

              其他的藥品沒有那么幸運,仍在FDA機構審查中,由于政府關門,上市時間表難以確定,僅列出審查截止時間。

              同時,還有一些在年底提交或即將提交的藥品,這些也是2019年不可忽視的王牌產品:

              艾伯維希望在2019年推出其新的類風濕性關節炎競爭者Upadacitinib,,而諾華公司此前在12月申請了黃斑變性藥物Brolucizumab。

              艾蒙尼在政府關閉之前提交的花生過敏項目AR101的申請處于擱置狀態,FDA機構專員Scott Gottlieb先生指出,像AR101這樣的過敏產品不包括在用戶費用計劃中,所以FDA在關閉期間沒有資金繼續審查。無論如何,這三個項目都將在今年啟動。阿斯利康和Fibrogen的Roxadustat(腎性貧血藥)也包括在內。

              Gottlieb同時在推特中指出,政府關閉造成了很多困難,特別是對于依賴FDA幫助提供的產品和保護的患者和消費者。但不能排出有一些政黨利用關閉的借口來推進誤導性的敘述。

              當然,作者同時指出,表中預測的TOP10新藥并不一定都會取得成功,由一份2018年同期預測表格來看,Incyte的Epacadostat(抗癌藥、IDO抑制劑)或許是2018年最大的一次失敗,免疫腫瘤項目進入市場的機會仍然非常渺茫。同樣,艾伯維的抗體-藥物結合物Rova-T(抗小細胞肺癌藥)看起來注定要被放棄。同樣,今年的新藥也可能遭遇無法預料的數據或技術問題,從而嚴重背離預期。

              參考資料:

              http://www.evaluate.com/vantage/articles/data-insights/other-data/us-shutdown-rolls-blockbuster-launches-line-2019

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