Akari Therapeutics, Plc 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 the company's lead drug candidate currently in two Phase III programs. The FDA agreed that the new manufacturing process produces drug that is comparable to nomacopan from the prior manufacturing process. The new manufacturing process increases the final yield of nomacopan at least 5-fold, compared to the previous manufacturing process, which will significantly decrease future commercial cost of goods and reduce the cost of ongoing Phase II/III and future clinical development programs for nomacopan.
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