Citius Pharmaceuticals, Inc. is gearing up to reintroduce a drug for cutaneous T-cell lymphoma (CTCL) onto the market as it prepares to submit new Phase III data for I/Ontak (denileukin diftitox) to the US Food and Drug Administration. The company hopes to benefit from physicians’ prior experience and familiarity with an earlier version of the treatment.
I/Ontak is a recombinant fusion protein combining the interleukin-2 receptor binding domain with diphtheria toxin fragments. It’s a reformulated version of Eisai’s Ontak, which the company voluntarily removed from the market in 2014 in order to remove unfolded proteins. But when it resubmitted it to the FDA, the agency determined that it constituted a new drug, requiring a new lead-in trial. Eisai Co., Ltd
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