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Amgen Successfully Expands Xgeva Label in the U.S. - Analyst Blog

Amgen 's ( AMGN ) Xgeva was approved by the FDA for another indication in the U.S. Xgeva's label was expanded for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. Amgen's shares gained 1.4% following the news.

The drug was also granted orphan drug designation for this indication.

Xgeva was approved to be administered as a subcutaneous injection (120 mg) for patients suffering from HCM every four weeks with additional doses of 120 mg on days eight and 15 of the first month of therapy.

We note that Xgeva is already approved for the prevention of skeletal-related events (SREs) in patients having bone metastases from solid tumors. However, it is not indicated for the prevention of SREs in patients with multiple myeloma. The drug is also approved for the treatment of giant cell tumor of bone in adults and skeletally mature adolescents, which cannot be treated with surgery.

Our Take

We are encouraged by the successful label expansion of the drug. Currently Novatis' ( NVS ) Zometa is approved for the treatment of HCM.

Xgeva is already an important product at Amgen. The drug contributed $896 million for the first nine months of 2014, an increase of 22% from the year-ago period.

Amgen has progressed well with its pipeline and is expecting several data readouts and regulatory decisions in the coming quarters. We expect investor focus to stay on these decisions.

Amgen is a Zacks Rank #1 (Strong Buy) stock. Some other stocks worth considering include Cytokinetics, Inc. ( CYTK ) and Biogen Idec Inc. ( BIIB ). Both carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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