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news.The FDA has granted orphan drug designation to Molecular Insight Pharmaceuticals' Ultratrace MIBG for the treatment of neuroendocrine tumors such as carcinoid, neuroblastoma, and pheochromocytoma.
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With orphan drug designation, Ultratrace MIBG is eligible to receive up to seven years of exclusivity in the US following marketing approval, as well as tax credits for R&D, protocol assistance, and reduced filing fees for marketing applications. Orphan drug designation is awarded to potential treatments for rare and very serious conditions.
Ultratrace MIBG is a targeted radiopharmaceutical that is designed to maximize delivery of radiolabeled MIBG molecules so that neuroendocrine tumors can be effectively diagnosed and treated.
According to the company, Ultratrace technology greatly reduces the amount of non-radioactive MIBG molecules, thereby enhancing tumor accumulation of therapeutic radiation.
The compound is currently in preclinical development and an investigational new drug application (IND) is currently under review at the FDA.