18 June 2015 - XOMA Corporation, a company involved in the discovery and development of therapeutic antibodies, has received Orphan Drug Designation from the US Food and Drug Administration for its XOMA 358, a fully human allosteric monoclonal antibody that decreases both the binding of insulin to its receptor and downstream insulin signalling, it was reported on Wednesday.The product is intended for the treatment of congenital hyperinsulinism. The designation provides the company with a seven-year period of United States marketing exclusivity and tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance, and waiver of Prescription Drug User Fee Act filing fees.Paul Rubin, MD, senior vice president, Research and Development, and chief medical officer at XOMA, said: "The orphan drug designation for XOMA 358 recognizes its potential to address a significant unmet medical need for patients with congenital hyperinsulinism. Patients with hyperinsulinism, a rare and devastating disease, secrete inappropriate and excessive insulin, which cause dangerously low blood sugar levels that can lead to brain damage or, in rare cases, death. Currently options to manage many of these patients are limited to continuous ingestion of glucose or pancreatectomy."