FDA requires additional trial for review of HyBryte, a proposed treatment for early stage cutaneous T-cell lymphoma .- Soligenix, Inc.,
Soligenix, Inc. announced that the Company convened a Type A Meeting with the FDA.
During the Type A Meeting, representatives of the Company and the FDA discussed the contents of a refusal to file (RTF) letter previously issued by the FDA regarding the Company's new drug application (NDA) for HyBryte (synthetic hypericin sodium) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it successfully demonstrated statistically significant results in a Phase III clinical trial (Study HPN-CTCL-01; also referred to as the FLASH study).
In order to accept an NDA filing for HyBryte, the FDA is requiring positive results from a second clinical study in addition to the Phase III, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. The FDA indicated that it is open to engaging in protocol discussions regarding the second clinical study. Based on the feedback, the Company has decided to collaboratively engage in discussions with the FDA in order to define the protocol and evaluate the feasibility of conducting the additional clinical trial.
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