06:38 AM EDT, 05/06/2024 (MT Newswires) -- MannKind ( MNKD ) said Monday it received US Food and Drug Administration fast track designation for clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial lung disease.

Fast-track designation eases the development and speeds up reviews of drugs treating serious conditions for which there are few if any treatments.

The designation came ahead of ICoN-1, an international, randomized, double-blind, placebo-controlled trial to begin in June evaluating the efficacy and safety of clofazimine inhalation suspension when added to guideline-based therapy in adults with refractory nontuberculous mycobacterial lung disease.

The FDA has already designated clofazimine inhalation suspension as both an orphan drug and a qualified infectious disease product. Both designations extend the drug's exclusivity period.

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