DBV Technologies has announced that the FDA has agreed to review the company’s Viaskin Peanut patch for potential regulatory approval.
Daniel Tassé, DBV’s CEO, called the acceptance of the company’s biologics license application (or BLA) “a meaningful step forward.” He thanked the more than 1,000 patients living with peanut allergies who took part in clinical trials of the skin patch therapy.
“We look forward to continuing to work with the FDA to potentially bring Viaskin Peanut to patients in the second half of 2020,” Tassé said in a press release on October 4.
The FDA told the company it will hold an advisory committee review of the Viaskin Peanut application. In this process, both the safety and the efficacy of a biologic drug is weighed.
The proprietary patch is designed to reduce the risk of peanut-allergic reactions in children aged 4 to 11 through a skin patch method (known as epicutaneous immunotherapy). The Viaskin patch, worn on the back and changed daily, exposes the patient to microgram quantities of peanut protein to stimulate the immune system.
Results of two controlled clinical trials were included in the submission. DBV is also investigating the potential of this form of Viaskin patch therapy for milk and egg allergies.
DBV Technologies had voluntarily withdrawn its earlier submission in December, 2018 after the FDA told the pharmaceutical company that its application to approve the desensitizing peanut patch for children lacked certain detail. In resubmitting its application in August 2019, the company said it had addressed “the additional data needed on manufacturing procedures and quality controls.”
In September, a committee reviewed Aimmune Therapeutics’ Palforzia peanut oral immunotherapy for safety and efficacy. The panel recommended that the FDA approve the OIT product. If the FDA follows the recommendation, Palforzia, formerly known as AR101, would become the first approved food allergy therapy.
If Viaskin Peanut also reaches approval, this would launch a new era of approved treatment options for food allergy patients.