Core Insights - Citius Pharmaceuticals has received a permanent J-code (J9161) for its drug LYMPHIR, effective April 1, 2025, which will facilitate billing and reimbursement for healthcare providers [2][3][4] - LYMPHIR is approved for treating adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy [1][9] - The establishment of the J-code is expected to enhance patient access to LYMPHIR, particularly for those with commercial and government insurance [4][5] Company Overview - Citius Pharmaceuticals, Inc. is focused on developing and commercializing first-in-class critical care products, with LYMPHIR being a key asset approved by the FDA in August 2024 [30] - Citius Oncology, a subsidiary of Citius Pharmaceuticals, is dedicated to oncology therapies and has a market estimate for LYMPHIR exceeding $400 million, indicating a growing and underserved market [29] - The company has robust intellectual property protections, including orphan drug designation and pending patents, which support its competitive positioning in the oncology market [29] Product Details - LYMPHIR is a targeted immune therapy that combines the IL-2 receptor binding domain with diphtheria toxin fragments, specifically designed to deplete immunosuppressive regulatory T lymphocytes and exhibit antitumor activity [6][9] - The drug has shown efficacy in clinical trials, with a focus on patients who have undergone at least one prior systemic therapy for CTCL [7][9] - Citius acquired exclusive rights to develop and commercialize LYMPHIR in all markets except Japan and certain parts of Asia [7] Market Context - Cutaneous T-cell lymphoma (CTCL) is the most common type of cutaneous lymphoma, significantly impacting patients' quality of life due to severe symptoms [8] - The disease typically affects men more than women and is often diagnosed in individuals aged 50 to 60 [8] - Current treatment options for advanced CTCL are limited, with no curative therapies available other than allogeneic stem cell transplantation for a small fraction of patients [8]
Citius Pharmaceuticals and Citius Oncology Announce Unique Permanent J-Code Issued for LYMPHIR by Centers for Medicare and Medicaid Services