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Actinium gets Orphan Drug Designation for myeloid leukaemia drug

pharmafile | March 31, 2016 | News story | Research and Development Actinium Pharmaceuticals 

New York-based biopharma Actinium Pharmaceuticals (NYSE MKT: ATNM) has received orphan drug designation from the US FDA for Iomab-B, a radioimmunotherapeutic that conditions relapsed and refractory acute myeloid leukaemia (AML) patients for a bone marrow transplant (BMT).

The drug is a combination of BC8 – a novel murine monoclonal antibody – and iodine-131 radioisotope. A Phase III trial of Iomab-B is soon to begin, of 150 relapsed and refractory AML patients over the age of 55.

Sandesh Seth, executive chairman of Actinium, comments: “We are pleased to have been granted orphan drug status by the FDA for Iomab-B, particularly ahead of its pivotal Phase III clinical trial. There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone.

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“Orphan drug status for Iomab-B follows Actimab-A, which was granted the designation in November 2014. Orphan drug status provides Actinium with several development and financial incentives, including seven years of market exclusivity in the United States, if Iomab-B receives marketing approval and exemption from prescription drug user fees.”

The FDA grants orphan status to drugs and biologics used to treat or prevent rare diseases affecting fewer than 200,000 people in the US. The designation provides drugmakers with certain incentives, including a period of marketing exclusivity after regulatory approval, and certain grants and other discounts.

Joel Levy

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