新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 高血压 » Actelion公司肺动脉高压药物Opsumit获日本批准

Actelion公司肺动脉高压药物Opsumit获日本批准

来源:生物谷 2015-04-01 13:49

2015年4月1日讯 /生物谷BIOON/ --Actelion制药公司肺动脉高压药物Opsumit(macitentan)近日在监管方面收获第3个重大里程碑,该药近期获日本批准,作为一种每日一次的口服药物,用于肺动脉高压(PAH)的治疗,以延缓病情进展。此前,Opsumit已于2013年底接连获批在美国和欧盟2大主要市场上市。

Opsumit是Actelion公司另一款PAH口服药物Tracleer的继任者,后者是该公司最畅销的产品,2012年销售额高达15亿瑞士法郎。然而,Tracleer将于2015年面临专利悬崖,该公司正指望Opsumit来弥补Tracleer专利到期所致的销售损失,该药将与市面上的其他PAH药物竞争,包括吉利德的Letairis、拜耳的Adempas(riociguat)、辉瑞的万艾可(Vigra,即伟哥)、礼来的希爱力(Cialis)及相关仿制药。

Opsumit是一种双效内皮素受体拮抗剂(ERA),能够松弛肺动脉并降低血压,该药与同类其他药物一样都具有一个黑框警示,禁止用于孕妇,因为这类药物可能对胎儿造成伤害。Opsumit的安全性和疗效已在迄今规模最大、开展时间最长的PAH临床试验SERAPHIN中得到证实,有近40个国家151个中心参与了研究。数据显示,与安慰剂相比,10mg剂量Opsumit使发病/死亡风险显著降低45%,同时使PAH相关住院或死亡风险显著降低50%。

肺动脉高压(PAH)是一种罕见病,全球发病率仅为百万分之十五至五十,特征是肺动脉血压异常升高,该病是一种慢性、极度严重、致死性疾病。尽管PAH罕见,但在高危群体中发病率显著升高,如HIV感染者中发病率约为0.5%,镰状细胞病患者中发病率约2-3.75%,而系统性硬化症患者中的发病率高达7-12%。(生物谷Bioon.com)

英文原文:Actelion Ltd’s PAH Drug Opsumit Gets The Green Light In Japan

Actelion Ltd’s drug Opsumit was granted approval yesterday by the Japanese Ministry of Health, Labor and Welfare, for the treatment of pulmonary arterial hypertension

Actelion Ltd (OTCMKTS:ALIOF)’s pulmonary arterial hypertension drug, Opsumit, has won final approval from the Japanese Ministry of Health, Labor and Welfare. The decision, announced on Thursday, means the drug, also known by its chemical name macitentan can be launched immediately onto the local market.

Opsumit, , will be co-marketed in Japan by Actelion Pharmaceuticals Japan and NIPPON SHINYAKU CO L (OTCMKTS:NPNKF).

Pulmonary arterial hypertension is one of a broad group of disorders jointly described as pulmonary hypertension (PH). PAH causes very high blood pressure in the arteries extending between the heart and lungs. It is a chronic, lethal disorder with symptoms such as tiredness and loss of breath and heart failure. It is more prevalent in non-Hispanic blacks, women, and people aged 75 and over.

PAH is a rare disease affecting only 15-50 people per million around the world. However, the incidence rate is higher in high-risk patients would be individuals infected with HIV, who suffer a 0.5% occurrence rate; patients with systemic sclerosis have a prevalence of 7-12%, while the disease affects around 2-3.75% patients with sickle cell disease..

Opsumit, works as a dual endothelin receptor antagonist (ERA). It’s safety and efficacy of the drug was established by SERAPHIN, the largest, longest PAH final-stage trial study. 151 centers in almost 40 countries were used to undertake the study, which was concluded 2012.

The trial primarily tested mortality and morbidity rate in 287 PAH patients treated with either a 3 mg or 10 mg once-daily drug, Opsumit or a placebo pill. The results indicated that the 10 mg dose of Opsumit reduced combined mortality-morbidity rate by 45% as compared to the placebo. The trial results further reported at least 3% more adverse effects in Opsumit-treated patients than the placebo group. The common adverse effects included headache, nasopharyngitis, anemia, urinary tract infection, bronchitis, influenza and pharyngitis.

The SERAPHIN provided the basis of the Japanese approval for Opsumit. This was further backed by positive results from a local study of the drug. In both studies, PAH affected volunteer patients exhibited pulmonary vascular resistance improvements, a 6 min walk distance (6MWD), and WHO functional class.

The oral drug Opsumit becomes the third major drug in Actelion’s PAH drug portfolio alongside Epoprostenol "ACT" and Tracleer. The intravenous treatment option for PAH, Epoprostenol “ACT” was granted approval in Japan back in February 2013. The drug is marketed in US under the brand name Veletri. The oral endothelin receptor antagonist Tracleer has been approved in Japan since 2005.

Opsumit, however, has prominence over the other two PAH drugs under Actelion’s umbrella. Tracleer has been known to cause abnormal enzyme elevations in the liver, so that patients are required to endure liver monitoring every month. Epoprostenol “ACT” has to be injected which makes it a more stable but inconvenient PAH treatment option.

Satoshi Tanaka, President of Actelion Japan, described Opsumit’s improvement over Actelion’s previous PAH treatments, "Opsumit represents a major step forward for the management of PAH as the first and only approved PAH treatment with proven long-term outcome efficacy.”

Actelion Chief Executive Officer, Jean-Paul Clozel, described Japaneseapproval of Opsumit as “a great achievement for Actelion Japan.”

in October 2013 Opsumit received approval from the US Food and Drug Administration, whilst European approval arrived in December 2013. and was given the go-ahead in Europe by. The drug is currently being launched in the Australia, Canada, the EU Switzerland and the US.

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库