Molecular Insight receives orphan designation for tumour treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation to Ultratrace MIBG (iobenguane I 131), developed by Molecular Insight Pharmaceuticals in the US for treating neuroendocrine tumours.
The US Food and Drug Administration (FDA) has granted orphan drug designation to Ultratrace MIBG (iobenguane I 131), developed by Molecular Insight Pharmaceuticals in the US for treating neuroendocrine tumours.
Ultratrace MIBG is the Cambridge, Massachusetts-based biopharmaceutical company's second lead product candidate and is designed to maximise delivery of radiolabeled MIBG molecules so that tumours can be effectively diagnosed and treated, and to minimise the amount of non-radioactive MIBG molecules that are delivered in the drug. The compound is currently in preclinical development and an Investigational New Drug application (IND) is currently under review by the FDA.
Ultratrace technology greatly reduces the amount of non-radioactive MIBG molecules, or cold contaminants, by several orders of magnitude, thereby enhancing tumour accumulation of therapeutic radiation.
Orphan drug designation, will give Ultratrace MIBG up to seven years of exclusivity in the US following marketing approval, as well as tax credits for research and development, protocol assistance, and reduced filing fees for marketing applications.