DBV Tech Nabs FDA Breakthrough Status for Peanut Allergy Patch

2015-04-13

突破性疗法免疫疗法快速通道

April 10, 2015 By Alex Keown, BioSpace.com Breaking News Staff WASHINGTON – Federal regulators awarded French company DBV Technologies SA a breakthrough status for its Viaskin Patch treatment for peanut allergies. The award marks the first time the U.S. Food and Drug Administration has awarded a breakthrough designation for food allergies, the company said in a press release. The FDA awarded Viaskin the breakthrough status designation after DBV reported positive Phase IIb results that showed 250 micrograms of Viaskin Peanut significantly and positively impacted peanut allergies in children. According to a company statement, the trial showed 50 percent of patients responded positively to the patch, compared to 25 percent of those who received a placebo – a statistically significant difference. Overall, Viaskin Peanut 250 micrograms showed better results than Viaskin Peanut 100 micrograms or 50 micrograms, the company said. Pierre-Henri Benhamou, chief executive officer of DBV Technologies, said the FDA’s breakthrough designation “highlights the urgent need to find a treatment for this life-threatening disease, and we are committed to bringing Viaskin Peanut to the market as quickly as possible.” The Phase IIb trial results were so promising there were numerous rumors of larger pharmaceutical companies courting DBV for a possible takeover, sending the company’s market value close to $1 billion. However, company officials told Bloomberg News the company wanted to remain independent. The company also said the mid-stage clinical trials demonstrated “an excellent safety pro all age groups.” Viaskin is an electrostatic patch, based on Epicutaneous Immunotherapy, which administers an allergen directly onto the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream. Breakthrough Therapy Designation is intended to expedite the development and review of drugs/biological products for serious or life-threatening diseases or conditions, such as peanut allergy. In 2012 the Viaskin Peanut Patch was awarded a Fast Track designation by the FDA. DBV Technologies (DBVT), a clinical-stage specialty biopharmaceutical company, is preparing a Phase III trial of Viaskin Peanut in children suffering from peanut allergy. French-based DBV Technologies, which formed in 2002, developed a proprietary, technology for administering an allergen to intact skin while avoiding transfer to the blood, which lowers the risk of an allergic reaction in the event of accidental exposure. DBV Technologies is focusing on food allergies for which there are currently no effective treatments. Peanut allergies have been diagnosed more often, jumping to 5.1 percent of children in 2011, compared to 3.4 percent allergic to peanuts from the previous decade, Bloomberg reported. There's no definitive treatment for peanut allergy, but desensitization is showing promise, the Mayo Clinic reported. Desensitization involves giving children with peanut allergies increasing doses of peanut flour or peanut extract over time. In addition to its Viaskin treatment of peanut allergies, DBV is also in a Phase I trial testing the drug against milk allergies and is in pre-clinical trials to test the compound against dust mite allergies. BioSpace Temperature Poll After last week's news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?

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