DBV Technologies Release: Clinical Development Program Receives FDA “Fast Track Designation” and Encouraging Phase Ib Safety Results for Viaskin® Peanut
2/28/2012 6:17:06 AM
BAGNEUX, France--(BUSINESS WIRE)--DBV Technologies announced today that it has received “Fast Track Designation” for the Clinical Development Program of its Viaskin® Peanut, a product designed for the treatment by Epicutaneous Immunotherapy (EPIT) of patients with peanut allergy. Products in the FDA’s Fast Track program normally receive priority review, and DBV could also be eligible to submit a U.S. BLA (Biologics License Application) on a rolling basis. This permits the FDA to review sections of the BLA in advance of receiving the complete set of clinical data.
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