Amgen, Inc. (NASDAQ:AMGN) announced that the FDA has approved its supplemental Biologics License Application (sBLA) to expand the label of its key drug, Xgeva.
Xgeva is currently approved for the prevention of skeletal-related events (SREs) in solid tumors in patients with bone metastases. With the latest FDA approval, the label of Xgeva will be expanded to include patients with multiple myeloma.
The FDA decision comes earlier than the PDUFA date of Feb 2, 2018. A similar regulatory application is also under review in the EU.
In the past year, Amgen’s shares have returned 13.8% in contrast to 1.7% decrease registered by the industry.
The FDA approval was based on safety and efficacy from the pivotal phase III '482 study, which enrolled 1,718 patients. The head-to-head study, which compared Xgeva to Novartis AG’s (NYSE:NVS) Zometa (zoledronic acid), met the primary endpoint of non-inferiority of the drugs in delaying the time to first on-study SRE in patients with multiple myeloma.
Bone complications in patients with multiple myeloma can be quite damaging. Until now, bisphosphonates were the only treatment option available for bone protection in multiple myeloma patients. However, bisphosphonates may cause renal toxicity and lead to renal impairment. Xgeva, which is not cleared through the kidneys, offers a better treatment option for such patients.
Xgeva is key revenue driver for Amgen and generated revenues of $1.18 billion in the first nine months of 2017, up 3% year over year. We expect approval for the expanded patient population to help in further boosting sales of the drug.
Amgen carries a Zacks Rank #3 (Hold).
Better-ranked biotech stocks are Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and Exelixis, Inc. (NASDAQ:EXEL) , both with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vertex’s stock has returned 87.9% in the past year while earnings estimates for 2018 have gone up by almost 3% in the past 30 days.
Earnings estimates for Exelixis have moved north by 1.4% in the past 30 days while the stock price has increased 79.9% in the past year.
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Novartis AG (NVS): Free Stock Analysis Report
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