FDA首次授予食品过敏领域突破性藥物(BTD)資格

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2015年4月9日讯 /生物谷BIOON/ --法國生物技能公司DBV Technologies在研的一款花生过敏贴片Viaskin Peanut近日喜获FDA“使人垂涎”的冲破性療法认定（BTD），這也是FDA初次授與食物过敏范畴BTD資历，突显了该范畴急迫的高度醫療需求。

Viaskin Peanut贴片操纵DBV公司的Viaskin平台開辟，可以或许渐渐练习人體免疫體系對花生發生耐受性。Viaskin是一種静電贴片，經由金大發,过程完备的皮膚递送生物活性物資（包含过敏原）而不粉碎皮膚，其理论根本為表皮免疫醫治( epicutaneous i妹妹unotherapy，EPIT），将过敏原直接递送至皮菲薄层，經由过程特异性靶向抗原提呈细胞（APCs）激活機體免疫體系，而不會让过敏原進入頸椎貼布,血液。今朝，Viaskin Peanut正被開辟用于醫治儿童花生过敏。除该產物，DBV公司也正在展開一項临床前实验和一項I期临床实验，别离查询拜访Viaskin贴片醫治尘螨过敏和牛奶过敏。

FDA授與Viaskin Peanut冲破性藥物质格，是基于一項IIb期临床实验（VIPES）的踊跃数据。该钻研證明高剂量（250ug）Viaskin Peanut贴片改良了儿童的花生过敏，有50%的儿童對贴片醫治有反响，而抚慰剂组仅為25%，差别具备统计学意义，到达了临床療效终点。别的，現有的平安性数据證明，Viaskin Peanut在所有春秋组中具备优秀的平安性。今朝，DBV公司正在踊跃筹辦在2016年启動一項III期临床实验，進一步伐查Viaskin Peanut在儿童花生过敏群體中的療效和平安性。

Viaskin Peanut的中期临床实验数据于2014年末颁布，那時就有傳言称DBV公司将成為某些制藥巨擘的收购方针，受傳言刺激，该公司市值飙升至10亿美元。不外DBV公司客岁在接管彭博社采访時暗示甘愿单干，该公司估计Viaskin Peanut贴片将在2018年上市。（生物谷Bioon.com）

英文原文：DBV snags a 'breakthrough' tag for its peanut allergy drug

French biotech DBV Technologies picked up the FDA's coveted breakthrough-therapy designation for its in-development peanut allergy patch, promising a speedy review as it works toward Phase III.

DBV's candidate uses its Viaskin platform, delivering allergens into the skin through an electrostatic patch and gradually training the i妹妹une system to tolerate peanuts. With the breakthrough tag, DBV is guaranteed access to top FDA officials as it develops Viaskin Peanut and a truncated review process once it submits the patch.

The FDA's move follows positive Phase IIb data in which the highest dose of Viaskin Peanut met its primary efficacy goal, getting 50% of patients to respond to therapy compared to 25% on placebo, a statistically significant difference. With those results in hand, DBV is plotting to launch a Phase III trial early next year, and the breakthrough designation--the first for a food allergy treatment--affirms Viaskin Peanut's promise, the company said.

Beyond its lead candidate, DBV is美白牙膏, at work on a Phase I Viaskin product for milk allergy 養生保健品,and a preclinical candidate designed to combat dust mite aversions. The patch is engineered to stick to the skin and deliver proteins into the body without breaking the skin, getting antigen美容整形,s to their target i妹妹une cells without letting them seep into the bloodstream, DBV says.

The mid-stage results for Viaskin Peanut, unveiled late last year, spurred rumors of takeover interest for the Paris-headquartered DBV, sending the company's market value toward the $1 billion mark. But DBV would rather go it alone, management told Bloomberg at the time, believing its top prospect can hit the market by 2018.