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Amgen's (AMGN) Xgeva Gets EU Approval for Expanded Label
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Biotech major Amgen Inc. (AMGN - Free Report) announced that the European Commission has approved its regulatory application, which was looking to expand the current indication for Xgeva for the prevention of skeletal-related events in patients with multiple myeloma.
Until now, Xgeva was approved for the prevention of skeletal-related events in patients with bone metastases from solid tumors. With the latest approval, the European label of Xgeva will be expanded to include patients with multiple myeloma.
The EU approval was expected as the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency had given a positive opinion recommending approval of Xgeva for this expanded patient population in February. In the United States, the FDA had granted approval for the same in January.
Though Amgen’s shares have declined 3.8% so far this year, it is still better than the 4.7% decrease registered by the industry.
The EU approval was based on safety and efficacy data from the pivotal phase III '482 study, which enrolled 1,718 patients. The head-to-head study, which compared Xgeva to Novartis AG’s (NVS - Free Report) 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 a key revenue driver for Amgen and generated revenues of $1.58 billion in 2017, up 3% year over year driven by higher demand. We expect approval for the expanded patient population in EU to help in further boosting sales of the drug.
Ligand’s stock has returned 17% this year so far while earnings estimates for 2018 and 2019 went up by more than 11% and 12%, respectively, in the past 60 days.
Earnings estimates for Regeneron moved north by 9% and 5% for 2018 and 2019, respectively in the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
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Amgen's (AMGN) Xgeva Gets EU Approval for Expanded Label
Biotech major Amgen Inc. (AMGN - Free Report) announced that the European Commission has approved its regulatory application, which was looking to expand the current indication for Xgeva for the prevention of skeletal-related events in patients with multiple myeloma.
Until now, Xgeva was approved for the prevention of skeletal-related events in patients with bone metastases from solid tumors. With the latest approval, the European label of Xgeva will be expanded to include patients with multiple myeloma.
The EU approval was expected as the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency had given a positive opinion recommending approval of Xgeva for this expanded patient population in February. In the United States, the FDA had granted approval for the same in January.
Though Amgen’s shares have declined 3.8% so far this year, it is still better than the 4.7% decrease registered by the industry.
The EU approval was based on safety and efficacy data from the pivotal phase III '482 study, which enrolled 1,718 patients. The head-to-head study, which compared Xgeva to Novartis AG’s (NVS - Free Report) 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 a key revenue driver for Amgen and generated revenues of $1.58 billion in 2017, up 3% year over year driven by higher demand. We expect approval for the expanded patient population in EU to help in further boosting sales of the drug.
Zacks Rank and Stocks to Consider
Amgen carries a Zacks Rank #3 (Hold). Some better-ranked biotech stocks include Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , both with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s stock has returned 17% this year so far while earnings estimates for 2018 and 2019 went up by more than 11% and 12%, respectively, in the past 60 days.
Earnings estimates for Regeneron moved north by 9% and 5% for 2018 and 2019, respectively in the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>