Actinium Pharma (ATNM) Commences EMA Scientific Advice Process for Iomab-B
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Actinium Pharmaceuticals, Inc. (NYSE: ATNM) announced that the Company has initiated the European Medicines Agency (EMA) Scientific Advice process for Iomab-B. The EMA provides scientific advice to companies regarding the appropriate studies for the development of a medicine. The goal of scientific advice is to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefits of patients.
The Scientific Advice process allows Actinium to dialogue with regulators from the EMA to determine the appropriate development program for Iomab-B in Europe. The EMA created this program to increase the probability of positive outcomes and to reduce the risk of objections during the evaluation of a market-authorization application. Iomab-B, Actinium’s lead drug candidate, has been granted orphan designation in the European Union (EU) by the EMA. Iomab-B is intended to be used, upon marketing authorization, in preparing patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55 for a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT). Iomab-B is currently in a 150 patient multicenter, pivotal Phase 3 trial that is being conducted in the United States.
Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals said, “We are very excited about the potential of Iomab-B in Europe to address an urgent unmet medical need. We believe Iomab-B is a potentially revolutionary therapy for relapsed or refractory AML patients who are over the age of 55 that could benefit from a bone marrow transplant. This remains a patient population that is drastically underserved on a global scale. Today’s initiation for scientific advice, together with our SME status and orphan designation for Iomab-B in the EU, is invaluable as we explore the regulatory pathway for Iomab-B in the EU. We will continue to drive the development of Iomab-B in the U.S. and beyond as we endeavor to bring Iomab-B to all patients that could potentially benefit from this drug candidate.”
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