Xgeva revenue trends
In 2Q17, Amgen’s (AMGN) Xgeva generated revenues of ~$395 million, which reflected ~4% growth on a YoY (year-over-year) basis and a 2% decline on a QoQ (quarter-over-quarter) basis. In 2Q17, in the US, Xgeva generated revenues of ~$292 million, which reflected ~6% YoY growth and a ~2% QoQ decline.
Outside the US, the drug generated revenues of around $103 million in 2Q17, compared with $104 million in 2Q16.
For more on Xgeva, please refer to Market Realist’s “Xgeva Is Expected to See Robust Revenue Performance in 2017.”
Recent regulatory submissions
In June 2017, the FDA (US Food and Drug Administration) accepted Amgen’s (AMGN) sBLA (supplemental Biologics License Application) to include Xgeva for the prevention of fractures and other SRE (skeletal-related events) in patients with multiple myeloma. The FDA has provided a PDUFA (Prescription Drug User Fee Act) action date of February 3, 2018.
Amgen submitted the sBLA based on safety and efficacy data from the pivotal phase-3 482 study. The phase 3 482 study demonstrated that Xgeva is non-inferior to zoledronic acid in delaying the time to the first on-study SRE (primary endpoint) in individuals with multiple myeloma. However, the study did not meet its secondary endpoint in demonstrating superiority in delaying time to its first SRE and its first-and-subsequent SRE.
In November 2010, the FDA approved Xgeva (denosumab) for the prevention of SREs in patients with bone metastasis from solid tumors.
Notably, Amgen’s Xgeva gives tough competition to Novartis’ Zometa. Amgen’s peers in the bone metastasis drug market include Bayer (BAYZF), Novartis (NVS), and Roche Holdings (RHHBY). The Vanguard High Dividend Yield ETF (VYM) invests ~1.34% of its total portfolio holdings in AMGN.