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诺华重磅药物Jakafi添新适应症,每年轻松进账超$10亿

  1. Jakafi
  2. 真性红细胞增多症
  3. 诺华
  4. 骨髓疾病

来源:生物谷 2014-12-05 16:31

Jakafi将轻松成为重磅药物,2个适应症(骨髓纤维化,真红)将分别每年为诺华带来超过5亿美元的进账。

2014年12月5日讯 /生物谷BIOON/ --近日,诺华肿瘤管线又新添了一枚重磅产品,FDA已批准Jakafi(ruxolitinib)新适应症,用于真性红细胞增多症(polycythemia vera,PV)的治疗。Jakafi通过FDA的优先审查程序批准,成为FDA批准用于真性红细胞增多症(PV,简称“真红”)的首个治疗药物。此前,Jakafi已于2011年11月获FDA批准用于骨髓纤维化(myelofibrosis)的治疗,该药也是FDA批准的首个骨髓纤维化药物。

今年3月,当诺华和合作伙伴Incyte公布Jakafi真性红细胞增多症(PV)III期临床数据之际,行业分析师早已按捺不住激动的心情,纷纷预测Jakafi将轻松成为重磅药物。此次Jakafi顺利赢得FDA芳心将使这些预测转变为现实。瑞士Vontobel银行分析师Andrew Weiss接受路透社采访时表示,预计Jakafi的2个适应症,将分别给诺华每年带来超过5亿瑞士法郎(约合5.67亿美元)的进账。

FDA便是根据该项III期数据批准了Jakafi,数据显示,Jakafi同时降低了真性红细胞增多症(PV)患者的脾脏大小及进行静脉抽血以控制病情的必要性。真性红细胞增多症(PV)是一种原因未明的造血干细胞克隆性疾病,属于骨髓增殖性疾病范畴,临床以红细胞数及容量显著增多为特点,出现多血质及高黏滞血症所致的表现,常伴脾大。PV起病隐袭,进展缓慢,晚期可发生各种转化。

目前,诺华也正在调查Jakavi用于胰腺癌及其他晚期恶性肿瘤的治疗。Jakafi是一种JAK1/JAK2(Janus相关激酶)抑制剂。JAK抑制剂类药物具有非常大的市场潜力,辉瑞的JAK抑制剂Xeljanz(tofacitinib)一直在类风关治疗市场上处于领先地位。(生物谷Bioon.com)

英文原文:Incyte's Jakafi gets a boost with FDA nod for bone marrow disease

Analysts in March foresaw Incyte's ($INCY) Jakafi easily topping the blockbuster mark when it met its goals in a Phase II trial in certain patients with a rare type of bone marrow disease. Now, with the FDA's official green light, it's time for Incyte to get working on turning those predictions into reality.

The orphan drug, known as Jakavi outside the U.S. where Novartis ($NVS) has full commercialization rights, Thursday became the first treatment to win the FDA's go-ahead to treat patients with polycythemia vera, a chronic condition marked by the overproduction of red blood cells.

U.S. regulators based the blessing on a Phase III trial that saw the med reduce both spleen size in patients and the need for phlebotomies to control the disease, according to Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases," he said in a statement.

Those trial results had analysts crying "blockbuster" nearly 9 months ago when Novartis announced it would this year be using them as a basis for regulatory filings around the globe. Vontobel analyst Andrew Weiss told Reuters at the time that he predicts the drug will bring in 500 million Swiss francs ($567 million) per year for each indication Novartis can add to the drug's label.

The Swiss pharma giant is also testing Jakavi, initially approved to treat blood cancer myelofibrosis, in pancreatic cancer and other advanced malignancies.

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