Amgen's Xgeva garners FDA approval to prevent cancer-related bone injury in patients with metastatic cancer

The FDA approved Amgen's Xgeva (denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumours, the company announced. The drugmaker said that approval of Xgeva was based on the results of three late-stage studies comparing the RANK ligand inhibitor to Novartis' Zometa (zoledronic acid).

In one trial of 1901 patients with prostate cancer, Amgen's drug delayed fractures and complications by an average of 21 months, compared to 17 months for Zometa. In a further study of 2046 patients with breast cancer, the drug also delayed fractures or complications longer than Zometa, while Amgen's drug was shown to be non-inferior to Novartis' drug in patients with other tumour types.

The drug is not indicated for the prevention of SREs in patients with multiple myeloma, Amgen noted. Roger Perlmutter, vice president of R&D at Amgen, noted that in patients with multiple myeloma, Zometa performed better than Xgeva, and the company is starting a new study in this indication. The company indicated that adverse events were similar between the two drugs in the clinical trials, and there was no significant difference between the therapies in occurrences of osteonecrosis of the jaw.

Amgen has also filed regulatory applications for Xgeva in Europe and several other markets, and in Japan, where it is working with partner Daiichi-Sankyo, an application was filed in August.

Citigroup analyst, Yaron Werber, said the FDA decision "will help put the company back on a growth trajectory," adding that sales of Xgeva may reach $2.4 billion in 2015. However Goldman Sachs analyst, Sapna Srivastava, who recently forecast Xgeva revenue of $1.3 billion in 2013, noted that the product's comparatively high price and safety issues will limit sales. Amgen noted that Xgeva will cost $1650 per month. Still, UBS analyst, Matthew Roden, said that the skeletal-related event indication for Xgeva represents the largest overall market opportunity for the drug.

In June, a lower-dose of Xgeva was approved in the US, under the brand name Prolia, as a treatment for postmenopausal women with osteoporosis at high risk of fractures. Revenue generated from this indication topped just $10 million in the third quarter, falling far below analysts' estimates of $31 million. Werber indicated that sales could increase a further $500 million annually if data expected later this year show that the drug can prevent prostate cancer from spreading to bone.

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