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.