Soligenix Gets Refusal to File Letter for HyBryte in Cutaneous T-Cell Lymphoma

The FDA has issued Soligenix a Refusal to File letter for its HyBryte (synthetic hypericin) new drug application (NDA), deeming it not sufficiently complete for a substantive review.

Soligenix said it will review the letter and determine next steps which could include requesting a meeting with the FDA to seek additional guidance on what the agency wants to see in a resubmitted NDA.

A candidate treatment for patients with early-stage cutaneous T-cell lymphoma, HyBryte includes a potent photosensitizer. The drug is applied to skin lesions and taken up by malignant T-cells, then activated by visible light approximately 24 hours later.

The investigational drug has received Orphan Drug and Fast Track nods from the FDA.