DBV snags 1st food allergy drug 'breakthrough' status
This article was originally published in Scrip
French drug maker DBV Technologies has been granted breakthrough therapy designation by the FDA for Viaskin Peanut, an investigational treatment for peanut allergy in children.
The Bagneux, France-based company is the first to snag the designation for a food allergy drug.
Shares of DBV leaped 7.6%, or $1.99, in mid-afternoon trading on 9 April.
The breakthrough therapy designation is aimed at expediting the development and review of products intended to treat life-threatening conditions.
To gain the status, which was created under the Food and Drug Safety Administration and Innovation Act, a drug must be intended to treat a serious condition and have preliminary clinical evidence that indicates the medicine may demonstrate substantial improvement on at least one clinically significant endpoint over available therapies.
DBV said the FDA granted the breakthrough designation to Viaskin Peanut based on positive results from the firm's Phase IIb VIPES study, which demonstrated the drug at 250mcg improved peanut allergy disease in children.
The company said available safety data from past and ongoing studies with Viaskin Peanut have demonstrated the drug has an "excellent" safety profile in all age groups.
In close coordination with the FDA, DBV said it is preparing to launch a Phase III trial of Viaskin Peanut in children with peanut allergy.
As of 20 March – the most recent date for which data are available – the FDA's Center for Drug Evaluation and Research had granted at least 71 of the 244 requests for the breakthrough designation it has received since July 2012, with regulators denying at least 121.
As of 31 March, the FDA's Center for Biologics Evaluation and Research had granted at least 11 of the 49 requests it has received for breakthrough status, denying at least 34.
At least two breakthrough therapy designations have been withdrawn after being granted.
Bristol-Myers Squibb has acknowledged that it accepted the FDA's decision to rescind two of the company's breakthrough therapy designations for its daclatasvir-based combinations after receiving a notice in February of the agency's plans to do so.