CRANFORD, N.J. - Citius Pharmaceuticals, Inc. (NASDAQ: NASDAQ:CTXR), a late-stage biopharmaceutical company, has announced the FDA's acceptance of its resubmitted Biologics License Application (BLA) for LYMPHIR™, an immunotherapy treatment for cutaneous T-cell lymphoma (CTCL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for August 13, 2024.
The BLA for LYMPHIR™, which is designed for patients with relapsed or refractory CTCL after at least one prior systemic therapy, follows a Complete Response Letter (CRL) issued by the FDA in July 2023. Citius believes it has adequately addressed the FDA's requests for enhanced product testing and additional manufacturing controls, with no new safety or efficacy concerns raised.
Leonard Mazur, Chairman and CEO of Citius, expressed confidence in the clinical data and the potential of LYMPHIR™ to meet a critical unmet need for CTCL patients. The BLA submission is supported by a pivotal Phase 3 study, and no further trials have been required by the FDA.
CTCL, a type of non-Hodgkin lymphoma, manifests as skin lesions and can severely impact the quality of life due to pain and pruritus. LYMPHIR™, which has received orphan drug designation for both CTCL and peripheral T-cell lymphoma (PTCL), is a recombinant fusion protein combining the interleukin-2 receptor binding domain with diphtheria toxin fragments.
Citius Pharmaceuticals focuses on developing first-in-class critical care products. Besides LYMPHIR™, the company has completed enrollment in a Phase 3 trial for Mino-Lok®, an antibiotic lock solution, and a Phase 2b trial for CITI-002, a topical hemorrhoid treatment.
The company has announced plans to form Citius Oncology, a separate publicly traded entity with LYMPHIR as its primary asset. The details of this press release are based on a press release statement from Citius Pharmaceuticals.
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