Citius Aims To Use Prior Experience With CTCL Drug To Its Commercial Advantage

The company announced positive data for I/Ontak, a reformulated version of the cutaneous T-cell lymphoma drug Ontak and aims to submit for approval later in 2022.

Citius announced results of its Phase III trial of I/Ontak in cutaneous T-cell lymphoma • Source: Alamy

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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