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Innovation Passport Granted For CRN04777 For The Treatment Of Congenital Hyperinsulinism
Innovation Passport Granted For CRN04777 For The Treatment Of Congenital Hyperinsulinism
Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted CRN04777 an "Innovation Passport" for the treatment of congenital hyperinsulinism (HI), which enables Crinetics to access the Innovative Licensing and Access Pathway (ILAP). The ILAP was launched in the United Kingdom in 2021 with the goal of reducing the time to market for innovative medicines that treat life-threatening or seriously debilitating conditions and/or conditions for which there is a significant unmet patient need. The ILAP aims to achieve this goal by enabling enhanced coordination between sponsors and MHRA leading up to Marketing Authorization Application (MAA) submissions and by providing the opportunity for accelerated MAA reviews.
"Congenital HI is a rare, life-threatening condition afflicting infants and young children that can lead to complications such as seizures, coma, and brain damage. Many children with the disease require intensive 24-hour glucose management, which is extremely burdensome and of limited efficacy," stated Scott Struthers, Ph.D., Crinetics' president and CEO. "We believe the Innovation Passport provides important external validation for the CRN04777 program and shows that the MHRA recognizes the struggle congenital HI patients and caregivers face each day. We are pleased to gain access to an expedited review pathway in the UK and look forward to developing CRN04777 as a potential effective oral therapy with the prospect to avoid many of the side effects and burdens associated with current treatments."
About the MHRA Innovation Passport
The MHRA Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market, facilitating patient access to new medicines including new chemical entities, biological medicines, new indications and repurposed medicines. An ILAP designation is linked to a portfolio of activities through the product specific creation of a Target Development Profile (TDP). The TDP will define key regulatory and development features, identify potential pitfalls and create a road map for delivering early patient access to designated product candidates. The TDP will include details about how sponsors can work with other UK stakeholders for coordinated and efficient evidence generation and evaluation and address commercial and managed access considerations. More information on TDPs and the ILAP is available on the UK government website.
Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted CRN04777 an "Innovation Passport" for the treatment of congenital hyperinsulinism (HI), which enables Crinetics to access the Innovative Licensing and Access Pathway (ILAP). The ILAP was launched in the United Kingdom in 2021 with the goal of reducing the time to market for innovative medicines that treat life-threatening or seriously debilitating conditions and/or conditions for which there is a significant unmet patient need. The ILAP aims to achieve this goal by enabling enhanced coordination between sponsors and MHRA leading up to Marketing Authorization Application (MAA) submissions and by providing the opportunity for accelerated MAA reviews.
亚洲网加利福尼亚州圣克拉拉8月23日电CRinetics制药公司(纳斯达克股票代码:CRNX)今天宣布,英国药品和保健品监管局(MHRA)已向CRN04777颁发了治疗先天性高胰岛素血症(HI)的“创新护照”,使Crinetics能够获得创新许可和准入途径(ILAP)。ILAP于2021年在英国启动,目标是缩短创新药物的上市时间,这些药物治疗危及生命或严重虚弱的疾病和/或有重大未得到满足的患者需求的疾病。ILAP旨在通过加强赞助商和MHRA之间的协调来实现这一目标,从而导致提交营销授权申请(MAA),并提供加速MAA审查的机会。
"Congenital HI is a rare, life-threatening condition afflicting infants and young children that can lead to complications such as seizures, coma, and brain damage. Many children with the disease require intensive 24-hour glucose management, which is extremely burdensome and of limited efficacy," stated Scott Struthers, Ph.D., Crinetics' president and CEO. "We believe the Innovation Passport provides important external validation for the CRN04777 program and shows that the MHRA recognizes the struggle congenital HI patients and caregivers face each day. We are pleased to gain access to an expedited review pathway in the UK and look forward to developing CRN04777 as a potential effective oral therapy with the prospect to avoid many of the side effects and burdens associated with current treatments."
Crinetics首席执行官兼首席执行官斯科特·斯特拉瑟斯博士说:“先天性HI是一种罕见的危及生命的疾病,会导致癫痫发作、昏迷和脑损伤等并发症。许多患有这种疾病的儿童需要24小时强化的血糖管理,这是极其繁重且效果有限的。”我们相信,创新护照为CRN04777计划提供了重要的外部验证,并表明MHRA认识到先天性HI患者和照顾者每天面临的斗争。我们很高兴能够在英国获得快速审查途径,并期待将CRN04777开发为一种潜在的有效口腔疗法,有望避免许多与当前治疗相关的副作用和负担。
About the MHRA Innovation Passport
The MHRA Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market, facilitating patient access to new medicines including new chemical entities, biological medicines, new indications and repurposed medicines. An ILAP designation is linked to a portfolio of activities through the product specific creation of a Target Development Profile (TDP). The TDP will define key regulatory and development features, identify potential pitfalls and create a road map for delivering early patient access to designated product candidates. The TDP will include details about how sponsors can work with other UK stakeholders for coordinated and efficient evidence generation and evaluation and address commercial and managed access considerations. More information on TDPs and the ILAP is available on the UK government website.
关于MHRA创新护照
MHRA创新护照是ILAP的切入点,该计划旨在加快上市时间,方便患者获得新药,包括新的化学实体、生物药物、新的适应症和重新调整用途的药物。ILAP指定通过创建特定于产品的目标开发配置文件(TDP)链接到一系列活动。TDP将定义关键的监管和开发功能,识别潜在的陷阱,并制定路线图,使患者能够及早接触到指定的候选产品。TDP将详细说明赞助商如何与英国其他利益攸关方合作,协调有效地生成和评估证据,并解决商业和管理准入方面的考虑。有关TDPS和ILAP的更多信息可在英国政府网站上找到。
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