Additional Relevant Details
"Congenital hyperinsulinism is a devastating disease that presents in infancy and leads to profound hypoglycemia, which can cause significant morbidities, including brain damage, seizures and epilepsy. Both the disease and current treatments have potentially life-long physical and psychological impacts on patients and their families.  The EMA Orphan Drug Designation for CHI recognizes the significant unmet medical need for CHI patients, and is an important step in the development pathway for XOMA 358," said Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer at XOMA. "The CHI community has been very supportive of our efforts to advance the XOMA 358 clinical program. With Orphan Drug Designation now secured in both the US and EU, we will continue to work closely with agencies in both regions to design a regulatory pathway that will expedite the clinical development for XOMA 358."