Biotechnology giant Amgen says the US Food and Drug Administration wants more information about its osteoporosis treatment Prolia before granting it market approval.
The FDA wants to know how Amgen will monitor patients who use the drug, and wants the company to create a strategy to evaluate its risks.
The news delays the drug, seen as a potential blockbuster for the company, with Amgen shares falling three per cent in pre-market trading.
The company wants to market Prolia for the prevention and treatment of post-menopausal osteoporosis. The FDA said Amgen needs to run more clinical tests of Prolia as a preventive therapy.
The Thousand Oaks, California-based company expects a separate response to its application for Prolia as a treatment for bone loss caused by hormone deprivation therapy.
Amgen has been a driving force in the biotechnology field for more than 25 years.
The company has discovered and developed innovative human therapeutics and invested in cutting edge manufacturing capability and support services to deliver therapies to medical teams around the world.
Copyright Press Association 2009
Food and Drug Administration