Citius Pharma Announces BLA Filing For Denileukin Diftitox - Quick Facts

(RTTNews) - Citius Pharmaceuticals, Inc. (CTXR) has submitted a Biologics License Application to the FDA for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK. The company noted that its BLA is supported by a phase 3 study.

In 2011 and 2013, the FDA granted orphan drug designation to I/ONTAK for the treatment of PTCL and CTCL, respectively.

Leonard Mazur, CEO of Citius, said: "The BLA filing for denileukin diftitox marks the first of our pipeline candidates to be submitted for FDA approval."

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