US FDA accepts resubmission of Amgen's Prolia
This article was originally published in Scrip
The US FDA has accepted a resubmission of Amgen's bone drug Prolia (denosumab) for the treatment of postmenopausal osteoporosis (PMO) and set a PDUFA date of July 25th, 2010. After disappointing drug sales for Amgen in 2009, analysts are increasingly looking to the drug to provide the company with a much needed life float.
"[A six-month review] for Prolia in PMO was largely anticipated and in line with our expectations," wrote Jefferies analysts in a research note. The analysts noted that they are not changing their 2010 sales estimate for the product – $104 million.
The resubmission comes in reply to a complete response letter that was issued by the agency last year (scripnews.com, October 19th, 2009). It reportedly requested several items, including information on the design of Amgen's previously submitted post-marketing surveillance programme and updated safety data, but additional clinical trials were not needed for this indication.
Just days later, Prolia was also rejected for prevention of postmenopausal osteoporosis and for the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients (scripnews.com, October 22nd, 2009). Amgen says it is continuing to work with the FDA to determine the appropriate steps forward for these indications.
In the EU, the first-in-class RANK ligand inhibitor was recommended in December by the CHMP for treatment of PMO and for bone-loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. It was not filed in the EU for the prevention of PMO indication.