Research & Development
The US FDA accepts Citius Pharmaceuticals' denileukin diftitox Biologics License Application
2 December 2022 -

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), a US-based late-stage biopharmaceutical company, announced on Thursday that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for denileukin diftitox (I/ONTAK or E7777), an engineered IL-2-diphtheria toxin fusion protein to treat patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL).

The product, a recombinant fusion protein that integrates the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments, is a purified and more bioactive formulation of previously FDA-approved ONTAK. The Prescription Drug User Fee Act (PDUFA) target action date is 28 September 2023 and the BLA is supported by a pivotal Phase three study (NCT01871727).

Leonard Mazur, Citius chairman and CEO, said. 'The acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program. With an anticipated PDUFA date of 28 September 2023, we look forward to the potential approval of this therapeutic for patients with persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced disease have limited treatment options.'