新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » FDA信息 » 诺华向FDA提交B型脑膜炎疫苗Bexsero生物制品许可申请(BLA)

诺华向FDA提交B型脑膜炎疫苗Bexsero生物制品许可申请(BLA)

来源:生物谷 2014-06-17 15:58

2014年6月17讯 /生物谷BIOON/ --诺华(Novartis)6月17日宣布,已向FDA提交了B型脑膜炎球菌疫苗Bexsero的生物制品许可申请(BLA),寻求批准用于10-25岁人群,预防由B血清群(meningitis B)脑膜炎双球菌导致的侵袭性脑膜炎球菌病。今年4月,FDA已授予Bexsero预防B型脑膜炎的突破性疗法认定。目前,Bexsero已获欧盟、加拿大、澳大利亚批准,用于年龄在2个月以上的人群,Bexsero是首个也是唯一一个宽覆盖范围的B型脑膜炎球菌疫苗,用于帮助保护所有年龄段人群预防B型脑膜炎,包括婴儿。

脑膜炎很容易被误诊,虽然罕见,但可能导致严重的后果。有时尽管采取了适当的治疗,但发病后24小时内的死亡率仍高达10%。另一方面,约有20%的幸存者会留下终身残疾,例如脑损伤、听力障碍或肢体残缺等。因此,通过疫苗接种的预防措施是减少该疾病负担的最优方法。在发达国家,B型脑膜炎在婴儿中尤为高发。

脑膜炎球菌是细菌性脑膜炎的主要原因。5株主要的脑膜炎双球菌(A,B,C,W-135,Y)引发了全球大多数病例。在Bexsero上市之前,市售疫苗仅针对其中4株(A、C、W-135、Y)产生保护作用。Bexsero能够提供针对所有5株主要脑膜炎双球菌的免疫保护,是首个也是唯一一个宽范围的B型脑膜炎球菌疫苗。(生物谷Bioon.com)

英文原文:Novartis submits application to the FDA for meningitis B vaccine candidate Bexsero® to help protect US adolescents and young adults

-Submission follows receipt of Breakthrough Therapy designation in April 2014, highlighting unmet need for a licensed vaccine for serogroup B in the US
-Meningitis B is a rare but aggressive disease that can kill or cause serious life-long disability within 24 hours of onset, often with initial flu-like symptoms
-Bexsero, approved in 34 countries, was recently provided to two US universities under an Investigational New Drug designation in response to outbreaks

Basel, June 17, 2014 - Novartis announced today the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for marketing approval for the use of Bexsero® (Multicomponent Meningococcal Group B Vaccine [recombinant, adsorbed]) to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 years through 25 years of age. This submission initiates a rolling submission process for Bexsero to the FDA, following the receipt of a Breakthrough Therapy designation in April.

"Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases," said Andrin Oswald, Division Head, Novartis Vaccines. "With today's submission, we are one step closer to ensuring that no family in the US has to endure the loss of a loved one from vaccine-preventable meningitis."

Bexsero is the first broad coverage vaccine to help protect against meningitis B[11]. The vaccine is already approved in 34 countries including across the European Union, Canada and Australia[5],[6],[7],[8]. Since the launch of Bexsero in 2013, over half a million doses have been distributed worldwide[12].

In the US, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara (UCSB) following meningitis B outbreaks on their campuses under an Investigational New Drug (IND) designation from the FDA[9],[10],[12]. Further, the US Centers for Disease Control and Prevention (CDC) have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero[13].

Meningococcal disease can be easily misdiagnosed and while rare, it can have serious consequences, including lifelong disability and death within the first 24 hours of symptom onset[2],[3],[4]. It is most commonly caused by one of the five main serogroups of meningococcal bacteria (A, B, C, W-135 and Y)[14]. Prior to the development of Bexsero, vaccines were only available for four of the five serogroups of the meningococcus, and a vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against these serogroups that together cause the majority of cases in the world[14],[15].

Novartis is committed to working with US health authorities to help provide access to Bexsero for all at-risk groups. Meningococcal disease can have tremendous impact on individuals and their families. Vaccination is the best defense against a disease that can be aggressive, and leave little time for intervention.

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