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远藤睾酮替代疗法Aveed获FDA批准

来源:生物谷 2014-03-07 07:45

2014年3月7日讯 /生物谷BIOON/ --远藤国际(Endo International Plc)3月6日宣布,睾酮替代疗法Aveed获FDA批准,用于治疗男性性腺功能减退症(hypogonadism)。而此前,FDA已3次拒绝批准该药。远藤国际称,预计于3月份将Aveed推向市场。

Aveed(testosterone undecanoate,十一酸睾酮)是一种长效处方药,含有十一酸睾酮和蓖麻油,作为一种替代疗法,用于治疗成年男性内源性睾酮不足或缺乏,包括原发性性腺功能减退症(先天性或后天性)、性腺功能减退症(先天性或后天性),该药旨在使血清睾酮水平在正常范围内。

FDA已表达了对蓖麻油配方造成肺部血管堵塞及注射后反应相关并发症风险的担忧。去年5月,FDA拒绝批准Aveed,称该公司需要一个更好的计划,来管理与Aveed相关的风险。今年2月,一个消费者维权组织呼吁FDA推迟对Aveed的审查决定,称治疗睾酮水平低的药物,应附带有关心脏问题风险的强烈警告信息。

Aveed具有一个黑框警告,即严重肺部油微栓(pulmonary oil microembolism,POME)反应和过敏反应,该药应用于需要治疗且临床益处大于严重风险的患者群体。

当前的睾酮药物包括皮肤贴、短效注射剂和外用凝胶。目前,AbbVie公司的AndroGel是该市场的领导者,该药在2012年的销售额约12亿美元。

男性性腺功能减退症(hypogonadism)的特点是睾丸分泌的睾酮水平低,而睾酮负责维持肌肉的体积、骨骼生长和性功能。睾酮水平低可导致性欲减退、抑郁、疲劳。(生物谷Bioon.com)

英文原文:FDA approves Endo International's testosterone drug

(Reuters) - Endo International Plc said the U.S. Food and Drug Administration approved its thrice-rejected testosterone replacement therapy, Aveed, to treat male hypogonadism.

The company's shares rose 4.6 percent in premarket trading.

The regulator rejected the treatment last May, saying that the company needed a better plan to manage risks associated with the long-acting drug that contains testosterone and castor oil.

The FDA had expressed concerns about the risk of the castor oil in the formulation causing blockages in blood vessels in the lungs and of complications linked to post-injection reactions.

In February, a consumer advocacy group urged the FDA to delay its decision on Aveed, saying drugs treating low testosterone should carry strong warnings about the risk of heart problems.

Testosterone treatments currently include skin patches, short-acting injections and topical gels. AbbVie Inc's AndroGel, the market leader, generated about $1.2 billion in sales in 2012.

Male hypogonadism is characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth and sexual function. Low levels of testosterone can lead to a loss of libido, depression and fatigue.

Endo International, formerly known as Endo Health Solutions Inc, said it expected to launch Aveed in early March.

The Dublin-based company said on February 28 that it would change its name following its acquisition of Paladin Labs.

Endo International's shares closed at $76.47 on the Nasdaq on Wednesday.

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