Viaskin Peanut Application to be Resubmitted to the FDA

DBV Technologies has announced plans to again submit Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for potential pediatric peanut allergy therapy Viaskin Peanut.

The company’s BLA for the investigative drug was originally submitted late last year, and withdrawn by DBV after the FDA requested additional data on its manufacturing procedures and quality controls. The company now anticipates the application will be resubmitted in the second half of 2019.

Viaskin, an epicutaneous immunotherapy (EPIT) designed as a small patch that delivers peanut protein via patients’ backs to Langerhans cells, is seeking indication as a peanut allergy desensitizing drug in patients aged 4-11 years old.

After receiving FDA Fast Track designation in 2012 and Breakthrough designation in 2015, Viaskin Peanut is again seeking consideration as the first therapy approved for the preventive care of peanut allergy—a condition that currently affects 1.5 million children in the US.

It would have competitors for such a title, however: Aimmune Therapeutics submitted a supplemental BLA for investigative biologic AR-101 in late December. The therapy is supported by the recent results of the phase 3 PALISADES trial, showing that two-thirds of treated patients were capable of ingesting 600-plus mg of peanut without dose-limiting symptoms at study’s end.

Regarding the Viaskin resubmission, DBV chief executive officer Daniel Tasse thanked the FDA for its “detailed feedback” which allowed the company to make headway in improving its application.

“We are working diligently on our Viaskin Peanut BLA, bringing us one step closer to potentially providing an FDA-approved treatment for peanut-allergic children and their families,” Tasse said in a statement.