The US FDA has hit Amgen with a complete response letter for its big hope, the bone drug Prolia (denosumab). While the agency has not requested more clinical studies for the postmenopausal osteoporosis (PMO) treatment indication, further trials are needed if it is to be approved as a preventative PMO therapy.
The response letter requested further information on the design of Amgen's post-marketing surveillance programme and updated safety data before the drug could be approved for treatment of PMO, however.