警惕糖尿病相关低血糖症!新型疗法Zegalogue在美国获得批准

2021-03-27 Allan MedSci原创

Zealand Pharma的注射疗法Zegalogue已获得美国食品药品监督管理局(FDA)的批准,可用于治疗糖尿病患者的严重低血糖症。

正常情况下,机体会将血糖水平保持在约 70-110 毫克/分升 (mg/dL) 或 3.9-6.1 毫摩尔/升 (mmol/L) 的范围内。在低血糖时,葡萄糖水平变得过低。虽然糖尿病表现为高血糖,但由于糖尿病治疗的副作用,许多糖尿病患者会周期性地出现低血糖。

Zealand Pharma的注射疗法Zegalogue已获得美国食品药品监督管理局(FDA)的批准,可用于治疗糖尿病患者的严重低血糖症。

Zegalogue(dasiglucagon)在6至17岁儿童1型糖尿病成人中进行的3项III期临床研究的功效数据支持了FDA的批准。对于所有这3个研究,主要功效终点是血浆葡萄糖恢复的时间,定义为自给药之日起血糖增加≥20 mg / dL,且在45分钟内未进行额外干预。

在儿科和成人人群中均成功实现了这一目标,与安慰剂相比,Zegalogue给药后患者10分钟血糖恢复中位时间“显著”更快,而安慰剂组的这一数据为30-45分钟。此外,在主要的III期成人试验中,有99%的患者在15分钟内恢复正常血糖水平。

 

原始出处:

http://www.pharmatimes.com/news/zealand_pharmas_hypoglycaemia_therapy_zegalogue_scores_approval_in_the_us_1365775

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    2021-03-28 1436749007

    我学到了很多东西谢谢老师

    0

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    2021-03-27 misszhang

    谢谢MedSci提供最新的资讯

    0

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