Iomab-B manufactured by Actinium Pharmaceuticals Inc. has been declared as orphan drug by European Medicines Agency for the treatment of patients with Acute Myeloid Leukemia (AML). The drug has the clinical tested usage in the treatment of patients with relapsed or refractory Acute Myeloid Leukemia (AML) with an age crossing 55 years. The major use of the drug is to prepare patients for bone marrow transplant also called as hematopoietic stem cell transplant (HSCT). Currently, it is undergoing phase III clinical trial with 150 patients in the US.
The EMA grants orphan designation to rare diseases that are defined as life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in the EU. With an estimated 30 million people living in the EU this equates to approximately 250,000 people or less for each rare disease.
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