The FDA has thrown up a roadblock for Amgen's bone drug denosumab, delaying its decision as the agency requests a new clinical program to support approval of the drug, along with more information on its post-marketing surveillance plan. But company executives and analysts alike say that the FDA's requests can be easily met, with no new clinical trials needed to support its application.
Investors, many of whom were looking for a quick approval and a near-term launch of a drug widely touted as a prospective blockbuster, weren't pleased by the hitch outlined in the FDA's complete response letter. Amgen's shares slid more than two percent on the news. Amgen's shares had climbed five percent last week as the FDA neared its deadline.
"We are confident that we can quickly respond to the FDA's requests for the treatment of post-menopausal osteoporosis indication and plan to do so in the near term," stated Roger Perlmutter, Amgen's executive vice president of research and development. And Geoffrey Porges, an analyst at Sanford Bernstein, agreed. "These are issues that look very doable," he told Reuters. "It shouldn't take long to get a risk management program in place that the FDA is comfortable with."
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