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MannKind吸入式胰岛素输送系统三期实验完成

来源:生物谷 2013-08-19 19:01

2013年8月19日讯 /生物谷BIOON/ --由MannKind公司研制的用于治疗一型和二型糖尿病的吸入式胰岛素输送技术Afrezza三期实验获得积极数据。MannKind公司研制的Afrezza利用了公司最新的冻干技术。在两项独立的研究中,Afrezza对一型糖尿病和二型糖尿病的疗效都达到了预定目标。

公司希望能够在今年的第四季度将Afrezza报送FDA审核。(生物谷Bioon.com)

详细英文报道:

MannKind ($MNKD) welcomed positive Phase III data for its inhaled insulin candidate Afrezza, a novel mealtime therapy for the treatment of Type 1 and Type 2 diabetes. The drug-device combination makes use of the company's dry powder tech to deliver insulin to the bloodstream immediately upon inhalation, controlling hyperglycemia.

In two separate studies, Study 171 for Type 1 and Study 175 for Type 2, Afrezza met its primary efficacy endpoints, showing that patients reached peak insulin levels within 12 to 14 minutes of administration, according to the company, mimicking the release of mealtime insulin in healthy individuals.

The dry powder technology uses MannKind's Technosphere platform, which is designed to act similarly to an injection. The powder form is characterized by rapid systemic absorption into the arterial circulation, according to MannKind, and can be used with a variety of drugs and proteins besides insulin. The advantages of the inhaled delivery of insulin include giving diabetics the option to avoid daily injections and bulky, glitchy pumps.

And MannKind's inhaler devices, in combination with the powder formulation, provide another level of convenient delivery for self-administration, a potential boon for the diabetes market.

"The positive results of Study 171 and Study 175 will form the basis of an amendment to our new drug application for Afrezza, which we expect to submit to the (FDA) early in the fourth quarter of this year," MannKind CEO Alfred Mann said in a statement.

The trial results put Afrezza in a league of its own in the inhaled insulin market, as Pfizer ($PFE) and Eli Lilly ($LLY) have both given up on their own versions. But MannKind has work yet to do before getting Afrezza past the FDA's rigorous standards for diabetes treatments.

 

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