Research & Development
Citius Pharmaceuticals receives additional guidance from FDA over LYMPHIR resubmission
11 September 2023 -

Citius Pharmaceuticals, Inc. ('Citius') (Nasdaq: CTXR), a late-stage biopharmaceutical company, announced on Friday that it has received additional guidance from the US Food and Drug Administration (FDA) over the proposed resubmission of its Biologics License Application (BLA) for LYMPHIR (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein.

The FDA has agreed with the firm's plans to deal with the needs outlined in the complete response letter (CRL) received 28 July 2023.

LYMPHIR is intended for the treatment of subjects with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after around one prior systemic therapy.

The guidance from the FDA offers the company a path for completing the required activities to help with resubmission of the firm's Biologics License Application (BLA) for denileukin diftitox. There were no additional clinical efficacy or safety trials that have been requested by FDA for the resubmission.