Associated tags: CTCL, FDA, Patient, BLA, Food, Pharmaceutical industry, Citius, Altius, Fortius, CRL, Regulation of tobacco by the U.S. Food and Drug Administration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Symantec Endpoint Protection, Safety
T-cell lymphoma,
PDUFA,
Symantec Endpoint Protection,
Letter,
Disease,
Patient,
CRL,
CTCL,
Drug development,
Safety,
FDA,
BLA,
Food,
Pharmaceutical industry CRANFORD, N.J., March 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024.
Key Points:
- "The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL.
- "We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative.
- We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL," added Mazur.
- The resubmission follows dialog with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.
Retrieved on:
Wednesday, February 14, 2024
CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
Key Points:
- The resubmission follows ongoing engagement with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.
- Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter.
- There were no safety or efficacy issues cited and no additional trials required.
- Based on Center for Drug Evaluation and Research timelines, FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act (PDUFA) date is expected within 30 days of resubmission.
Retrieved on:
Friday, September 8, 2023
CTCL,
CRL,
FDA,
Regulation of tobacco by the U.S. Food and Drug Administration,
Patient,
BLA,
Food,
Pharmaceutical industry,
Citius, Altius, Fortius CRANFORD, N.J., Sept. 8, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) is pleased to announce the Company has received additional guidance from the U.S. Food and Drug Administration (FDA) regarding the planned resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), 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.
Key Points:
- The FDA has agreed with the Company's plans to address the requirements outlined in the complete response letter (CRL) received July 28, 2023.
- The guidance from the FDA provides Citius with a path for completing the necessary activities to support the resubmission of the Company's Biologics License Application (BLA) for denileukin diftitox.
- No additional clinical efficacy or safety trials have been requested by FDA for the resubmission.
- "We are encouraged by the constructive engagement with the FDA," stated Leonard Mazur, Chairman and CEO of Citius.
CTCL,
FDA,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Patient,
BLA,
Symantec Endpoint Protection,
Food,
Safety,
Pharmaceutical industry,
Citius, Altius, Fortius CRANFORD, 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.
Key Points:
- The 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.
- "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.
