Posted on 19/07/2010 in Pharmaceutical Company Product News Amgen is to be granted priority review status from an industry regulatory body for denosumab, a treatment designed to reduce skeletal related events in patients with cancer.
The US Food and Drug Administration has allocated the status to Amgen's treatment based on data from a number of phase III studies, which illustrate the drug's benefits compared to Zometa.
This US submission is one of a number of regulatory applications currently pending for the drug, with Amgen having also submitted denosumab for approval in the EU, Australia, Canada and Switzerland.
Dr Roger Perlmutter, the company's executive vice-president of research and development, said the priority review designation illustrates the potential for the drug to represent a "meaningful advance" over the current standard of care.
He added: "In clinical trials, denosumab has consistently demonstrated an ability to reduce the burden of complications from skeletal metastases, with a positive benefit-risk profile."
Last week, Amgen announced the appointment of Jonathan Peacock as its new executive vice-president and chief financial officer.Other news stories from 19/07/2010
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