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Citius Pharmaceuticals, Inc. Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
No clinical efficacy or safety issues raised Citius committed to working toward approval CRANFORD, N.J., July 29, 2023 /PRNewswire/ -- Citius Pharmaceuticals,
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"No clinical efficacy or safety issues raised\nCitius committed to working toward approval\nCRANFORD, N.J., July 29, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the Company's Biologics License Application (BLA) seeking approval for denileukin diftitox (\"LYMPHIRTM\"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.\nThe FDA has required Citius to incorporate enhanced product testing, and additional controls agreed to with the FDA during the market application review. Importantly, there were no concerns relating to the safety and efficacy clinical data package submitted with the BLA, or the proposed prescribing information.\n\"We appreciate the FDA's expeditious review of our application. We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval. We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed or refractory CTCL and make a meaningful difference in their lives,\" stated Leonard Mazur, Chairman and CEO of Citius.\nAbout LYMPHIR™ (denileukin diftitox-cxdl)\nLYMPHIR is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. In 2011 and 2013, the FDA granted orphan drug designation to LYMPHIR for the treatment of PTCL and CTCL, respectively. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Subsequently in 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia.\nAbout Cutaneous T-cell Lymphoma\nCutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a r...