MannKind Gets FDA Clearance for Clofazimine IND Application
By Chris Wack
MannKind said the Food and Drug Administration has cleared its Investigational New Drug application for MNKD-101 Clofazimine inhalation suspension, enabling the initiation of a Phase 3 study for the treatment of nontuberculous mycobacterial lung disease.
The company said it expects to get this study underway by end of the second quarter 2024 in the U.S., and internationally in the second half of 2024.
The study is a randomized, double-blind trial to evaluate the efficacy and safety of Clofazimine inhalation suspension when added to guideline-based therapy in adults with refractory nontuberculous mycobacterial lung disease caused by mycobacterium avium complex.
MannKind said that in 2022, there were about 122,000 patients living with nontuberculous mycobacterial in the U.S.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 29, 2024 06:35 ET (10:35 GMT)
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