Neurochem Inc announced that it has initiated submission of a rolling new drug application (NDA) to the US FDA seeking marketing approval for Fibrillexâ„¢ (1,3-propanedisulfonate), Neurochem's oral investigational drug candidate for the treatment of the fatal inflammation-related disease Amyloid A (AA) Amyloidosis. Neurochem plans to complete the submission of the NDA within the next 3 to 4 months. As reported early this year, the results of Neurochem's single phase II/III trial were mixed. Neurochem will provide additional follow-up clinical data collected from an ongoing open-label extension study as part of its NDA submission.

AA Amyloidosis is a progressive and fatal condition that occurs in a proportion of patients with chronic inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, Familial Mediterranean Fever, and Crohn's disease. Renal dysfunction is the most common clinical presentation, with end-stage renal failure as the main cause of death in approximately 50% of cases. According to Neurochem, Fibrillex appears to delay the progression of renal disease and to be well tolerated. Neurochem has a collaboration and distribution agreement for Fibrillex with Centocor (Johnson & Johnson).