The Food and Drug Administration (FDA) has granted Orphan Drug designation to nomacopan (Akari Therapeutics) for the treatment of bullous pemphigoid.

BP is a rare, autoimmune, chronic skin disorder that causes blistering, urticarial lesions and itching. This condition is most common among older adults. Nomacopan is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity.

The Company is currently evaluating nomacopan in an ongoing phase 2 trial in patients with bullous pemphigoid and plans to present the new efficacy and safety data at the 28th European Academy of Dermatology and Venereology (EADV) Congress on October 10, 2019. 

“[Bullous pemphigoid], a severe blistering skin condition with no approved treatments, is an exciting therapeutic target for our lead drug candidate, nomacopan,” said Clive Richardson, Chief Executive Officer of Akari Therapeutics.”It is also a disease of increasing prevalence due to an aging population and improving diagnosis.”

Nomacopan is also being investigated for 3 additional indications: atopic keratoconjunctivitis, thrombotic microangiopathy (TMA), and paroxysmal nocturnal hemoglobinuria. The FDA has granted Fast Track and Orphan Drug designations to nomacopan for TMA.

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