DBV Technologies (NASDAQ:DBVT) is preparing for a potential U.S. launch of its peanut allergy patch for children ages 4 to 7 while awaiting a decision on whether regulators will accept its biologics license application, executives said at Guggenheim’s Healthcare Innovation Conference.
CEO Daniel Tassé said DBV filed the application for its lead VIASKIN product on Sept. 29 and expects a decision on acceptance in late November. The company has requested priority review, but that request has not yet been granted.
VIASKIN uses a patch to expose intact skin to a small amount of allergen, with the aim of desensitizing the immune system. Although the platform could have applications beyond food allergies, DBV is currently focused on pediatric patients, Tassé said.
Trial results and FDA review
In the pivotal study supporting the application for children ages 4 to 7, Tassé said 47% of patients receiving the active treatment met the efficacy measure at one year, compared with 14% receiving placebo. He described the measure as a substantial increase in the amount of peanut allergen required to trigger a reaction.
Tassé said immunotherapy typically involves three to five years of treatment and that DBV has an open-label extension in its program. He also cautioned that the company assessed efficacy after 12 months and does not have clinical data showing the level of protection after a few weeks or months.
DBV’s discussions with the Food and Drug Administration before filing focused on how manufacturing and biostatistical data were organized, rather than on generating new data, Tassé said. He added that the FDA had indicated in pre-filing meeting minutes that an advisory committee meeting did not appear necessary, subject to review. DBV is nevertheless preparing for one.
Manufacturer warning letter
Tassé acknowledged a risk that an FDA warning letter involving contract manufacturer Fareva’s facility in Amboise, France, might not be resolved before a pre-approval inspection. He said the observations involved sterile manufacturing of a veterinary product in another part of the facility, but the warning letter affects the site’s broader quality systems.
DBV is satisfied with Fareva’s pace in addressing the issues and has high confidence they will be resolved before the inspection, Tassé said. He added that sponsors typically invite the FDA to inspect after the mid-cycle review and that DBV had done so.
Toddler application and launch plans
DBV is also discussing the timing and process for an application covering children ages 1 to 3. Tassé said the FDA has one team reviewing both applications, creating a potential bottleneck, and that further details would follow those discussions.
The company’s COMFORT study is intended to add patients to the safety database for the younger group, rather than investigate a particular safety signal, Tassé said.
Chief Commercialization Officer Kevin Trapp said DBV estimates approximately 600,000 children have peanut allergies and plans to focus its sales efforts on allergists. The proposed launch would include roughly 50 to 70 specialty sales representatives and digital outreach to parents.
Trapp said pricing has not been finalized and will depend in part on the product’s label. If approved, DBV expects it could take weeks after the FDA action date to move supply from France through U.S. distribution.
Tassé said the company’s cash runway extends into the third quarter of the following year, including planned commercialization and inventory investments. That would take DBV through launch if the application receives priority review, he said, while noting that the company continues to consider financing options.
About DBV Technologies (NASDAQ:DBVT)
DBV Technologies SA (NASDAQ: DBVT) is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immune-mediated conditions. The company’s approach is based on epicutaneous immunotherapy, which is designed to deliver small amounts of an allergen through the skin to help desensitize the immune system.
DBV Technologies’ lead product candidate is Viaskin Peanut, an investigational patch intended to treat peanut allergy, particularly in children.
