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TauRx can confirm it has completed the request for information (RFI) received from the Medicines and Healthcare products Regulatory Agency (MHRA) in relation to its UK Marketing Authorisation Application (MAA) for hydromethylthionine mesylate (HMTM).
The only oral tau therapeutic to have completed Phase 3 trials, research suggests that if it is approved by regulators HMTM could slow the progression of Alzheimer’s disease – providing a major step forward in neurodegenerative disease research.
The company is committed to working with the MHRA and other bodies to address one of the world’s greatest unmet medical needs and eagerly awaits the outcome of the review.
Further updates on the application will be provided when appropriate.
TauRx完成对MHRA信息请求的回复
TauRx公司确认已完成英国药品和健康产品管理局（MHRA），就其甲磺酸氢甲硫堇（HMTM）英国上市许可申请（MAA）所要求的信息征询（RFI）。
作为首个完成III期临床试验的口服tau蛋白治疗药物，研究表明若获得监管批准，HMTM有望延缓阿尔茨海默病的恶化——这将成为神经退行性疾病研究的重大突破。
该公司致力于MHRA及其他相关机构通力合作，共同应对这一全球亟待满足的重大医疗需求，并热切期待评审结果的公布。
我们将适时提供该申请情况的最新动态。
