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喜讯!辉瑞肺炎疫苗临床试验大获成功!

来源:生物谷 2015-03-21 10:51

2015年3月21日 讯/生物谷BIOON/--辉瑞公司公布了其肺炎疫苗Prevenar13临床试验CAPiTA结果,数据已经在三月份的 《新英格兰医学》杂志上发表。(相关阅读:欧盟批准辉瑞肺炎疫苗Prevenar 13(沛儿13)用于18岁及以上成人群体)

肺炎链球菌是细菌性肺炎最常见的感染源,而Prevenar13是辉瑞公司开发的用于预防13种肺炎链球菌致病的疫苗。该疾病也是在全球范围内导致住院和死亡的主要原因。肺炎球菌病也同样可以导致儿童而不感染和其它多种疾病。

CAPiTA研究是近来有辉瑞公司与荷兰乌特勒支大学医学中心和Julius Clinical合作开展的,该研究用于评估Prevenar13对于第一阶段的肺炎球菌肺炎、侵入性肺炎球菌病和非细菌性获得性肺炎在65岁以上成年中的预防效果。受试者体质非常虚弱,因为他们脆弱的免疫系统已经无法保护他们免受肺炎和其它危及生命的细菌感染。

辉瑞公司宣布该疫苗已经达到了首次和第二次的研究目标,因为其可以保护病人在血液和其它无菌区域免于危险的感染。该实验共招募84496个受试者,其中一半接受Prevenar13,另一半给予安慰剂。试验结果表明该疫苗可以降低45.6%肺炎球菌肺炎的发生。

Prevenar13已经成为了全球范围内使用最广泛的用于预防肺炎链球菌感染的疫苗。全球已经有7.5亿份Prevenar疫苗售出,在历史上已成为第二大高利润的疫苗。该疫苗也同样是辉瑞第二大产生高收入的产品,在2014年为公司带来45亿美金的销售。目前在全球已有超过120个国家批准该疫苗上市,欧洲与今年2月批准,美国FDA也已经批准其用于6周到17岁的儿童和49岁以上的成年人。(生物谷Bioon.com)

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信源:bidness

生物谷推荐英文原文报道:

Pfizer Inc. Publishes Prevenar 13 Data From CAPiTA Study

Pfizer Inc. (NYSE:PFE) announced that the results from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), conducted to evaluate its blockbuster vaccine Prevenar 13, have been published in the March issue of the New England Journal of Medicine.

Prevenar 13 is a vaccine developed by Pfizer for protection against 13 strains of pneumococcal disease, which is known to be the most common cause of pneumonia due to bacteria. The disease is also known to be the leading cause of hospitalizations and deaths worldwide. Pneumococcal disease can also lead to ear infections and various other diseases in children.

The CAPiTA study was recently conducted by Pfizer in collaboration with the University Medical Centre Utrecht, situated in Netherlands, and Julius Clinical to evaluate the immunization efficacy of Prevenar 13 against first stage of vaccine-type pneumococcal Community-Acquired Pneumonia (CAP) and Invasive Pneumococcal Disease (IPD), and non-bacteremic/non-invasive CAP in adults 65 and older.

Patients among the said age group are particularly more vulnerable, as their weakening immune systems are not able to protect them against pneumonia and other life-threatening bacterial infections.

Pfizer announced that the vaccine met both primary and secondary endpoints specified for the study, as it proved to protect the patients from the said age group from the threatening infections found in the blood streams and other sterile regions of the body.

As many as 84,496 people were enrolled in the CAPiTA study, half of whom were given a dose of Prevenar 13, while the other half were given a placebo shot. In the study, Prevenar proved to reduce the CAP infections by as much as 45.6%.

Pfizer further said that more dangerous but less common bloodstream and various other invasive bacterial infections were shown to occur in 75% fewer patients who were receiving the actual vaccine shots, in comparison to the patients who were given the dummy shots.

Pfizer was required to conduct CAPiTA by regulatory bodies of various countries globally.

Prevenar 13 is well known to be the most commonly and widely used vaccine worldwide for protection against pneumococcal infections. Globally, as many as 750 million doses of Prevenar 13 are distributed and it stands to be the second-most lucrative vaccine drug in recorded history. The vaccine is also the second-highest revenue-generating product for Pfizer, bringing $4.5 billion in sales in 2014. Prevenar 13 is already approved in over 120 countries. The most recent approval granted to the vaccine came in February 2015 as the European Commission gave a green light for the expanded use of the drug to be administered in adults for protection against vaccine-type pneumococcal pneumonia. Following the approval, the Summary of Product Characteristics for Prevenar 13 was updated as the efficacy data was included in it.

The US Food and Drug Administration (FDA) has approved the vaccine for use in children aged six weeks to 17 years and in adults aged 49 and above. The recently published results for Prevenar 13 have also been submitted to the FDA. The results have further been submitted to regulatory bodies of other major markets globally, such as Canada and Australia, for the addition of the indication to the approved use of the vaccine.

The New England Journal of Medicine has recently received a lot of limelight from the media, as the data published in the journal has resulted in significant upward movement for the relevant stocks. The journal recently published data for two drugs which belong to the new generation of cholesterol-lowering drugs known as PCSK9 inhibitors; among these drugs, one was developed by Amgen, Inc. (NASDAQ:AMGN), while the other drug was developed by Sanofi SA (ADR) (NYSE:SNY) and Regeneron Pharmaceuticals Inc (NASDAQ:REGN). Stocks of all three companies soared on the back of the positive data from the recent studies that were published in the said journal.

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