FDA grants fast track designation to Viaskin Milk for milk allergy

The FDA granted fast track designation to an investigational treatment for pediatric patients aged two years and older with immunoglobulin E-mediated cow’s milk protein allergy, according to the drug’s manufacturer.

The Viaskin Milk (DBV Technologies) system, which delivers a precise quantity of the allergen to the skin, is intended to circumvent contact between the allergen and the bloodstream, conferring a greater level of safety as systemic reactions can be avoided.

Cow’s milk protein allergy (CMPA) is a common food allergy among infants and young children, affecting 2% to 3% of the population, with symptoms ranging from gastrointestinal problems to angioedema and anaphylaxis. Currently, there are currently no approved treatments for CMPA, leaving patients with the only option to avoid cow's milk, which can lead to issues of dietary imbalance.

“This achievement reinforces our commitment to bringing novel therapies to food allergic patients,” Laurent Martin, chief development officer at DBV Technologies, said in a press release. “We are the first to announce fast track designation in this indication, and Viaskin Milk is DBV’s second product candidate to secure an expedited review designation by the FDA.”

The FDA based its decision on efficacy and safety results from the ongoing phase 2b Viaskin Milk Efficacy and Safety (MILES) study, which evaluated the impact of three escalating doses of Viaskin Milk (150 micrograms, 300 micrograms and 500 micrograms) vs. placebo.

Additionally, a phase 2 clinical trial assessing Viaskin Milk for the treatment of milk allergy-induced eosinophilic esophagitis in children aged four to 17 years is also ongoing in collaboration with the Children’s Hospital of Philadelphia.

“CMPA is one of the most common food allergies in children, and a life-threatening disease for which there currently is no approved treatment, representing a major public health challenge,” Martin said in the release. “We look forward to working closely with the FDA throughout the development process of Viaskin Milk.”

The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow the company to work closely with the FDA to expedite the review of aspects of the Viaskin Milk system to improve the efficiency of product development.