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FDA Agrees to Use of New Manufacturing Process for Nomacopan in Clinical Studies

January 19, 2022

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Akari Therapeutics, Plc, a late-stage biopharmaceutical company focused on therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, has announced that the U.S. Food and Drug Administration ( FDA ) has agreed, via a Type C meeting, to the clinical use of nomacopan derived from a next generation manufacturing process. Nomacopan is Akari’s lead drug candidate currently in two Phase III programs.

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