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FDA委员会建议批准MannKind吸入性胰岛素产品Afrezza

来源:生物谷 2014-04-06 02:45

2014年4月6日讯 /生物谷BIOON/ --MannKind制药近日宣布,FDA内分泌和代谢药物顾问委员会(EMDAC)以13:1的投票结果,建议批准该公司开发的实验性吸入型胰岛素产品Afrezza(人胰岛素,重组DNA来源),用于1型糖尿病患者改善血糖控制;同时,该委员会还以14:0的投票结果,建议批准Afrezza用于2型糖尿病患者改善血糖控制。该委员会指出,需要开展更多的长期研究,监视Afrezza可能出现的副作用,如肺癌。如果获批,Afrezza将成为美国首个超速效(ultra rapid-acting)、餐时(mealtime)胰岛素疗法。

去年8月,MannKind宣布Afrezza的2项III期研究均取得了积极数据,在这2项独立的研究中,Afrezza对I型糖尿病和2型糖尿病的疗效都达到了预定目标。

Afrezza是一种新颖的超速效餐时胰岛素疗法,开发用于1型和2型糖尿病成人患者,以改善血糖控制。Afrezza是一种药物-设备组合产品,利用一种微小不起眼且易用的吸入器递送Afrezza吸入性粉末。在开始进餐时吸入,Afrezza吸入性粉末能够立即溶解到肺脏深部,并迅速递送胰岛素至血液,在给药12-15分钟内便可达到胰岛素峰值水平,而注射型速效胰岛素类似物产品和注射型人胰岛素产品则分别在注射后的45-90分钟和90-150分钟才能达到峰值。(生物谷Bioon.com)

英文原文:FDA Advisory Committee Recommends Approval of AFREZZA(R), MannKind Corporation's Investigational Drug to Treat Diabetes

VALENCIA, Calif., April 1, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 13 to 1 to recommend that AFREZZA® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes. If approved, AFREZZA would be the first ultra rapid-acting mealtime insulin therapy available in the United States.

"We are pleased with the Advisory Committee's approval recommendation in support of AFREZZA, and we appreciate the thoroughness of their review," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "We look forward to working with the FDA as they complete their evaluation of AFREZZA. Diabetes is a major health problem in the United States, and we are committed to bring AFREZZA to the many patients who might benefit from this novel product."
The FDA is not bound by the Advisory Committee's recommendation but will consider its guidance in reviewing the New Drug Application (NDA) that was submitted for AFREZZA. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of AFREZZA is April 15, 2014.

About AFREZZA®

AFREZZA® (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA Inhalation Powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.

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