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首页 » 心血病药物市场 » Actelion在美国推出肺动脉高压新药Opsumit

Actelion在美国推出肺动脉高压新药Opsumit

来源:生物谷 2013-11-06 07:08

2013年11月6日讯 /生物谷BIOON/ --Actelion公司11月4日宣布,在美国推出Opsumit(macitentan,10mg),该药为每日一次的口服片剂,用于治疗肺动脉高压(PAH),以延缓疾病进展。Opsumit是Actelion公司PAH药物Tracleer的继任者,Tracleer将于2015年失去专利保护。

Opsumit于2013年10月18日获FDA批准,并于10月25日获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准Opsumit,作为单药疗法或联合其他药物,用于肺动脉高压(PAH)成人患者(WHO功能分级II-III)的长期治疗。

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。Letairis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:ACTELION ANNOUNCES U.S. COMMERCIAL AVAILABILITY OF OPSUMIT (MACITENTAN) AS OF NOVEMBER 4

OPSUMIT -- indicated to delay disease progression and reduced hospitalizations in pulmonary arterial hypertension -- now available to patients

SOUTH SAN FRANCISCO - 4 November 2013 - Actelion (SIX: ATLN) today announced the commercial availability of OPSUMIT? (macitentan) 10mg, an oral, dual endothelin receptor antagonist (ERA) approved for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression. PAH is a chronic, life-threatening disorder that can severely compromise the function of the lungs and heart. The U.S. Food and Drug Administration (FDA) approved OPSUMIT on October 18, 2013.

OPSUMIT? is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). OPSUMIT also reduced hospitalization for PAH.

Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with OPSUMIT monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).

"OPSUMIT is a clinically proven treatment option that is the first drug to demonstrate, in a randomized, controlled study, delay in disease progression for PAH over the long term. I am very pleased to be able to offer my patients suffering from this debilitating disease a new treatment option," said Richard Channick, MD, director, Pulmonary Hypertension and Thromboendarterectomy Program, Massachusetts General Hospital, Boston.*

"The availability of OPSUMIT in the U.S. marks a significant milestone for physicians and patients. They now have a treatment option available that is shown to improve both short-term physical functioning and long-term PAH outcomes," said Bill Fairey, president of Actelion Pharmaceuticals U.S. "Actelion is committed to bringing this important treatment to patients suffering from PAH and has therefore established a patient support program to provide access to OPSUMIT."

"All of us at the Pulmonary Hypertension Association are excited when new treatments become available.  We know that not all treatments work for all patients and having new options - whether used alone or in combination with other therapies - means that physicians have more opportunities for helping their patients," said Rino Aldrighetti, president and CEO of the Pulmonary Hypertension Association.

The efficacy of OPSUMIT was established in the SERAPHIN study, a long-term study of 742 PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of two years. OPSUMIT is the only oral PAH treatment that has proven efficacy on long-term PAH outcomes and hospitalizations. [1]

Opsumit? carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Opsumit REMS Program. All female patients must be enrolled in the program, comply with pregnancy testing requirements and be counseled regarding the need for contraception.

The most common adverse reactions (more frequent than placebo by 3% or more) observed in patients treated with Opsumit? were anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.

Physicians are advised to measure hemoglobin and liver enzymes prior to initiation of Opsumit? and repeat during treatment as clinically indicated.

OPSUMIT is available in 10 mg tablets for once-daily oral administration.

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