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首页 » FDA信息 » Actelion公司肺动脉高压药物Opsumit获FDA批准

Actelion公司肺动脉高压药物Opsumit获FDA批准

来源:生物谷 2013-10-21 03:32

2013年10月20日讯 /生物谷BIOON/ --Actelion公司10月18日宣布,FDA已批准Opsumit(macitentan,10mg),作为每日一次的疗法,用于治疗肺动脉高压(PAH),以延缓疾病进展。该药是Actelion公司PAH药物Tracleer的继任者,Tracleer将于2015年失去专利保护。

Opsumit的获批,是基于在临床试验中可有效延缓疾病的进展。

Opsumit属于一类名为内皮素受体拮抗剂的药物,能够放松肺动脉并降低血压,Opsumit与该类药物中的其他药物一样,具有一个黑框警示,指出该药不可用于孕妇,因为Opsumit可能对胎儿造成伤害。

肺动脉高压(PAH)是一种极度严重的疾病,症状包括:呼吸短促、易于疲劳、晕厥、胸痛以及腿部和踝部水肿。此外,患者的肺动脉高压会逐步加重,甚至使寿命缩短。多数肺动脉高压相关的症状源自右心衰竭。

根据Actelion提供的数据,Tracleer在2012年的销售达15亿瑞士法郎,为该公司最畅销的药物。Actelion正指望Opsumit来弥补Tracleer专利到期所致的销售预期下降。

Opsumit将与市面上的其他PAH药物展开竞争,包括吉利德(Gilead)的Letairis,该药在美国以外国家和地区由葛兰素史克(GSK)以品牌名Volibris销售。(生物谷Bioon.com)

英文原文:U.S. FDA approves Actelion's lung disease drug Opsumit

Oct 18 (Reuters) - Actelion Ltd has won U.S. approval for its drug Opsumit, a successor to its pulmonary arterial hypertension drug Tracleer, which loses patent protection in 2015.

Pulmonary arterial hypertension, or PAH, is characterized by high blood pressure in the arteries connecting the heart to the lungs, which causes the right side of the heart to work harder than normal and causes shortness of breath.

Opsumit belongs to a class of drugs known as endothelin receptor antagonists, which relax the pulmonary arteries and decrease that pressure.

The drug, like others in its class, carries a boxed warning, the most serious possible, that it should not be used in pregnant women because it can harm the fetus.

The FDA based its approval on a clinical trial that showed Opsumit was effective in slowing progression of the disease.

The Swiss company reported sales of Tracleer in 2012 of 1.5 billion francs, making it the company's biggest selling product. Actelion is banking on Opsumit to make up for an expected decline in Tracleer sales once it loses market exclusivity.

Opsumit will compete with, among others, Gilead Sciences Inc.'s Letairis, which is sold outside the United States by GlaxoSmithKline Plc under the brand name Volibris.

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