Posted on 23/06/2009 in Pharmaceutical Company Product News Amgen looks forward to discussing results from its denosumab examinations with members of the Reproductive Health Drugs Advisory Committee (RHDAC), it has stated.
The company has been invited by the Food and Drug Administration to meet with the group on August 13th, when data supporting the biologics license application for the Rank Ligand inhibitor will be reviewed.
As well as seeking approval for the medication to prevent and treat bone loss in patients undergoing hormone ablation for prostate or breast cancer, Amgen is also trying to receive authorisation for the therapy to manage postmenopausal osteoporosis.
Dr Sean Harper, chief medical officer and head of global development at the firm, explained there is a call for a drug to help patients with these medical conditions.
"Although osteoporosis treatments are available, there remains a need for other options that deliver robust efficacy and support adherence to therapy," he said.
"We look forward to discussing the data from our denosumab trials in these settings with the members of the committee."
Last week, the 34 winners of the Amgen Award for Science Teaching Excellence were announced. Other news stories from 23/06/2009
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