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辉瑞向FDA提交B型脑膜炎疫苗生物制剂许可申请

来源:生物谷 2014-08-18 09:18

2014年8月18日讯 /生物谷BIOON/ --辉瑞公司和诺华公司两家一直在B型脑膜炎疫苗开发领域上进行着激烈的角逐,都希望成为第一个吃螃蟹的人。不过最近辉瑞公司表示公司已经向FDA申请审批获得生物制剂许可申请,FDA预计将在未来6个月内对辉瑞公司的B型脑膜炎疫苗rLP2086进行审批和回复。这是否意味着辉瑞已经在这场激烈角逐中占得先机?业界分析人士认为,这并不表明诺华公司已经落后。消息显示,诺华公司也几乎同时向FDA提交了BLA申请。

上周四FDA接受了辉瑞公司为其B型脑膜炎疫苗提交的生物医药授权申请(BLA)和有限审评审核,这也是药物开发中重要的里程碑。现有临床二期研究表明,辉瑞开发的rLP2086能够安全高效的激发患者体内的脑膜炎抗体。在提交FDA审核的同时,辉瑞公司还积极寻求扩大rLP2086的适用范围,此前辉瑞公司就已经和美国疾控中心进行协商,试图将这种疫苗的适用范围扩大至65岁以上。上个月月底,辉瑞公司还和Baxter公司签订价值6亿3千5百万美元的协议以扩大公司在疫苗市场推广的优势。(生物谷Bioon.com)

详细英文报道:

Pfizer ($PFE) and Novartis ($NVS) are in a dead heat to become the first vaccine maker to roll out a meningitis Bvaccine for the U.S. market. But the New York pharma giant just became the first of the two to snag a decision date from the FDA, which says it will have an answer on Pfizer's candidate within the next 6 months.

Thursday, the agency accepted Pfizer's Biologics License Application for its MenB contender, dubbed rLP2086, granting it priority review designation. Along with it came a PDUFA action date of February 14, 2015.

"Both the acceptance of Pfizer's Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents," Dr. Emilio Emini, Pfizer's SVP of vaccine R&D, said in a statement.

At one time, it looked like Novartis' rival jab, Bexsero, would beat rLP2086 to the regulatory finish line by a long shot. But impressive Phase II results showed that rLP2086 could safely spur the development of meningococcal disease-fighting antibodies in patients, convincing Pfizer to move ahead with its filing.

That doesn't mean Novartis' own PDUFA date is necessarily a long way off. Currently, the Swiss pharma is awaiting feedback from the FDA, a spokeswoman told FierceVaccines. But it filed its BLA the same day Pfizer did, meaning it could follow sooner rather than later.

In the meantime, as Pfizer waits for the FDA's verdict, it's working on bulking up its vaccines unit in other ways. Pfizer is "building on our world-leading Prevnar franchise, to expand the benefits of vaccines to more patients across ages and geographies," a spokeswoman told FierceVaccines. To that end, the company recently grabbed a CDC panel recommendation for universal use of the shot in adults over 65. And late last month, the New York-based drugmaker added to its marketed vaccines lineup, picking up a pair of shots from Baxter in a $635 million deal.

 

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