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首页 » FDA信息 » FDA批准默沙东超级HPV疫苗Gardasil 9,销售峰值将达到$19亿

FDA批准默沙东超级HPV疫苗Gardasil 9,销售峰值将达到$19亿

来源:生物谷 2014-12-11 16:25

2014年12月11日讯 /生物谷BIOON/ --默沙东(Merck & Co)近日收获了个大好消息,Gardasil(4价HPV疫苗)的接班人Gardasil 9(9价HPV疫苗)获得了FDA的批准。然而,坏消息是,Gardasil 9将取代Gardasil成为全球最畅销的HPV疫苗;Gardasil将退居二线,同时销售将大幅下滑。不过,反正2个都是自己的产品,默沙东就偷着乐吧。

近日,FDA批准Gardasil 9(人乳头瘤病毒9价疫苗,重组)用于预防由9种类型人乳头瘤病毒(HPV)导致的某些疾病,该疫苗覆盖了9种HPV类型,比已上市的Gardasil(4价HPV疫苗)多了5种。Gardasil 9具有预防大约90%的子宫颈、外阴、阴道和肛门癌症的潜力。

具体而言,FDA已批准Gardasil 9用于9-26岁的女性以及9-15岁的男性,用于预防由高危型HPV(16、18、31、33、45、52、58)导致的宫颈、外阴、阴道、肛门癌,以及预防由低危型HPV(6、11)导致的尖锐湿疣。Gardasil 9增加了针对额外5种类型HPV(31、33、45、52、58)的免疫保护,这5种类型HPV导致了大约20%的子宫颈癌,此前FDA批准的Gardasil未包括这5种类型HPV。

在美国开展的一项涉及14000例女性(16-26岁)的大型研究结果表明,Gardasil 9在阻断4种共有的HPV类型时与Gardasil具有同等的有效性;此外,研究人员确定,Gardasil 9预防5种额外HPV类型所致癌症的有效性高达97%。在9-15岁青少年(男性1200例,女性2800例)中开展的临床试验证实了Gardasil 9的有效性,数据显示,Gardasil 9在9-15岁青少年中诱导的抗体应答与Gardasil 9在16-26岁女性中诱导的抗体应答类似。Gardasil 9的安全性在大约13000例男性和女性中得到了证实。基于这些数据,FDA批准Gardasil 9用于9-26岁女性及9-15岁男性。

有分析师预计,Gardasil 9的年销售额峰值将达到19亿美元,该疫苗的大部分潜在市场份额将来自Gardasil。预计到2018年,Gardasil的销售额将萎缩至5.25亿美元,该疫苗在2013年的销售额一度高达18.3亿美元。

本周早些时期的一个好消息,也值得默沙东高兴高兴,在青少年女性中开展的一项研究发现,接种HPV疫苗并未导致高风险性行为的增加。(相关阅读:CMAJ:年轻女性接种HPV疫苗和高风险的性行为之间或并无关联)(生物谷Bioon.com)

英文原文:FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV

Merck's ($MRK) Gardasil follow-up is here, meaning blockbuster sales figures are likely on the way. But the bad news is that they'll come at the expense of the world's second-best-selling shot.

On Wednesday, the FDA approved Gardasil 9, which prevents cervical, vulvar, vaginal and anal cancers caused by the four HPV types its predecessor protects against, as well as an additional 5 types--31, 33, 45, 52 and 58--that cause approximately one-fifth of cervical cancers, according to the FDA.

In a study of approximately 14,000 females ages 16 through 26, Gardasil 9 proved as effective as Gardasil at blocking the four shared HPV types, and researchers determined it was 97% effective in preventing cancers caused by the 5 additional types.

While analysts estimate the new vaccine could rake in $1.9 billion a year at its peak, much of its potential market share will come at Gardasil's expense. Leerink has estimated the old vaccine will sink to just $525 million in 2018 sales for the New Jersey pharma giant--a far cry from last year's $1.83 billion tally.

But Merck may be able to amp up Gardasil 9's haul if it can overcome some of the uptake issues that have been plaguing the original shot since it hit the market. A variety of factors, including sex-related stigma, have weighed on sales, leading analysts to revise Gardasil sales predictions that once reached as high as $10 billion.

On that front, however, the company got some good news earlier this week: In a study of teen girls, HPV vaccination didn't lead to an increase in risky sexual activity, a new study showed.

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