Refusal to File Letter from FDA for HyBryte NDA in the treatment of cutaneous T-cell lymphoma
Soligenix, Inc. has announced that the FDA has provided the Company with a Refusal to File (RTF) letter for its HyBryte (synthetic hypericin) new drug application (NDA) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer and area of unmet medical need affecting over 25,000 patients in the U.S.
Upon preliminary review, the FDA determined that the NDA, submitted on December 14, 2022, was not sufficiently complete to permit substantive review. Soligenix first learned of the RTF decision via this letter and is reviewing its contents to determine the appropriate next steps, which includes, but is not limited to, requesting a Type A meeting with the FDA to clarify and respond to the issues identified in the letter and to seek additional guidance concerning information that the agency would require for a resubmitted NDA to be deemed acceptable to file.
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