7 Jul 2016
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for Araim Pharmaceuticals’ lead product candidate, Innate Repair Receptor activator ARA 290, for the treatment of sarcoidosis.
ARA 290 has previously been granted EU Orphan Drug Designation for the treatment of sarcoidosis, and has received US Orphan Drug and Fast Track designations for the treatment of neuropathic pain in patients with sarcoidosis.
What is Sarcoidosis?
Sarcoidosis is an uncommon inflammatory disorder that affects multiple organ systems and results in varied clinical signs and symptoms, often severe and disabling. Small fiber neuropathy (SFN) is a serious, potentially devastating complication of sarcoidosis that is being recognized with increasing frequency, with debilitating pain, abnormal sensory function, and severe dysautonomia as prominent manifestations. The precise pathophysiology of sarcoidosis SFN is unknown. No approved therapies are available, and off-label treatments remain symptomatic, inconsistent and limited.