Peanut Patch Receives FDA’s Breakthrough Therapy Designation

In positive news, DBV Technologies, a French firm developing skin patch therapies for various allergens, issued a press release announcing their Viaskin® Peanut patch has received “Breakthrough Therapy” (BT) designation from the US Food and Drug Administration (FDA).

DBV describes Viaskin as “an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.”

The FDA describes BT designation as follows:

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

The Viaskin Peanut patch received the BT designation after a positive Phase IIb trial – a relatively small trial intended to confirm that a therapy has some efficacy and is safe. DBV is preparing to launch its Phase III trial in children suffering from peanut allergy. Phase III trials are much broader and may involve 1000 or more patients.

While the news is encouraging, please keep in mind that even if the Viaskin Peanut therapy eventually receives FDA approval (which is in no way implied by the BT designation) it is still years away from general use.

The firm is also conducting clinical trials for milk and dust mite therapies.

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