Citius Pharmaceuticals, Inc. Holds Pre-BLA Meeting with the FDA for I/ONTAK (denileukin diftitox) for the Treatment of Cutaneous T-Cell Lymphoma

Biologics License Application (BLA) submission planned for the second half of 2022

CRANFORD, N.J. , July 12, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq:CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company held a Type B pre-BLA meeting with the U.S. Food and Drug Administration (FDA) to discuss I/ONTAK (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK^®. The pre-BLA meeting was held with representatives from the FDA's Center for Drug Evaluation and Research (CDER).