Citius Pharmaceuticals Seeks FDA OK of Reformulated Ontak Drug
September 28 2022 - 9:22AM
Dow Jones News
By Colin Kellaher
Citius Pharmaceuticals Inc. on Wednesday said it filed for U.S.
Food and Drug Administration approval of its lead product candidate
denileukin diftitox, also known as I/Ontak, for the treatment of
patients with persistent or recurrent cutaneous T-cell
lymphoma.
The Cranford, N.J., biopharmaceutical company said I/Ontak is a
purified and more bioactive formulation of Ontak, which Japan's
Eisai Co. pulled from the market in 2014 due to production issues
related to bacterial expression and purification challenges.
Citius last year acquired the exclusive license to denileukin
diftitox a late-stage oncology immunotherapy for the treatment of
cutaneous T-cell lymphoma, a rare form of non-Hodgkin lymphoma.
The company said manufacturing improvements have resulted in a
new formulation that features improved purity and bioactivity.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 28, 2022 09:07 ET (13:07 GMT)
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