Posted on 19/02/2010 in Pharmaceutical Company Product News Amgen has won the backing of the Food and Drug Administration (FDA) over its plans to assess the potential risks of its erythropoiesis-stimulating agent-based treatments.
Along with partner Centocor Ortho Biotech, it will execute a Risk Evaluation and Mitigation Strategy over brands such as Epogen and Procrit in order to provide more information about potential associated safety issues.
The FDA has backed Amgen's initiative and strategy based on the need to ensure that cancer patients using the treatments are aware of possible downsides such as increased tumour progression, so they can make an informed decision.
Dr Roger Perlmutter, executive vice president of research and development at Amgen, said the initiative was representative of the firm's commitment to safety and education.
He added: "This programme supports a thoughtful dialogue between healthcare providers and patients when considering ESA treatment."
Earlier this month, the company published trial data from a phase III study of its new cancer drug denosumab, in which it demonstrated its superior efficacy compared to an established alternative.Other news stories from 19/02/2010
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