The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Viaskin Peanut (DBV Technologies) for the treatment of peanut-allergic children aged 4 to 11 years.
The Company had initially submitted a BLA for Viaskin Peanut in October 2018 but withdrew the application in order to address data needed on manufacturing procedures and quality controls. The updated BLA was resubmitted in August 2019.
Viaskin Peanut, an epicutaneous immunotherapy (EPIT), delivers small amounts of peanut protein through a wearable patch to induce desensitization. The BLA is supported by data from two phase 3 trials (PEPITES and REALISE), four phase 2 trials, and two phase 1 trials.
PEPITES was a global, pivotal, double-blind, placebo-controlled,12-month trial that assessed the safety and efficacy of Viaskin Peanut 250mcg in children aged 4 to 11 years (N=356). Results showed a statistically significant response in 35.3% of patients treated with Viaskin Peanut compared with 13.6% of patients in the placebo arm (difference in response rates = 21.7%; P=.00001; 95% CI: 12.4%, 29.8%).
REALISE was a multicenter, randomized, double-blind, placebo-controlled, 36-month trial that evaluated the safety of Viaskin Peanut 250mcg in children aged 4 to 11 years (N=393). Results demonstrated Viaskin Peanut to be well-tolerated with no new or unexpected adverse reactions, similar to that observed in the PEPITES trial.
The FDA has set an action date of August 5, 2020 for the application. If approved, Viaskin Peanut would be the first epicutaneous patch indicated for the treatment of peanut allergy. “The acceptance of the Viaskin Peanut BLA is a meaningful step forward for peanut-allergic patients and their families,” stated Daniel Tassé, CEO of DBV Technologies. “We look forward to continuing to work with the FDA to potentially bring Viaskin Peanut to patients in the second half of 2020.”
For more information visit dbv-technologies.com.