Akari's Nomacopan Gets Orphan Drug Tag For Rare Disease
Zacks Investment Research | Sep 01, 2019 09:17PM ET
Akari Therapeutics, Plc (NASDAQ:AKTX) announced that the FDA has granted an orphan drug designation to its lead pipeline candidate nomacopan for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA). Currently, there is no approved therapy for this rare disease.
Notably, the orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States. This designation also makes the company entitled to certain other benefits including tax credits related to clinical study expenses and an exemption from certain administrative fees. The status also makes nomacopan eligible for seven years of marketing exclusivity in the United States.
Last month, the FDA granted a Fast Track designation to nomacopan for the same indication in the pediatric patient population. Akari plans to begin a pivotal study on the candidate for HSCT-TMA in the fourth quarter of 2019.
Shares of Akari have surged 32.5% so far this year against the Zacks Investment Research
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