Amgen's Xgeva Myeloma Label Expansion SBLA Accepted By FDA

Amgen Inc. (NASDAQ:AMGN) announced that the FDA has accepted 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. Amgen is looking to expand the label to include patients with multiple myeloma.

The FDA is expected to deliver a decision on the sNDA on Feb 3, 2018.

Xgeva is a fully human monoclonal antibody that inhibits bone breakdown by binding itself with RANK ligand and neutralizing it. Amgen’s shares have outperformed the Zacks classified Medical - Biomedical and Genetics industry so far this year. The stock gained 12.9% compared with the industry’s increase of 6.4% during the period.

The company had submitted the sBLA in April this year backed by data from a pivotal ‘482 study, which compared Xgeva to Novartis AG’s (NYSE:NVS) Zometa (zoledronic acid). The study met its primary endpoint and demonstrated that Xgeva is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma. Xgeva also achieved a median increase of 10.7 months in progression-free survival (PFS) compared with Zometa. Moreover, secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met.

The company will also apply for changes to its already submitted marketing authorization application to the European Medicines Agency (EMA), based on the data from ‘482 study.

In the phase III ‘482 study, 120 mg dosage of Xgeva was administered subcutaneously along with an intravenous placebo every four weeks. This administration was compared with 4 mg intravenous dose of Zometa and subcutaneous placebo every four weeks.

Per the press release, an estimated 114,000 new patients are diagnosed with multiple myeloma worldwide every year and there are more than 80,000 related deaths. The disease is characterized by osteolytic bone lesions and renal impairment. However, currently available treatments are associated with renal toxicity and the majority of the patients face the risk of renal impairment over the course of the disease. Upon approval, Xgeva will provide a way of treatment without affecting renal functions and may boost revenues by expanding market share.

Xgeva sales contributed more than 7.5% to Amgen’s total product revenue in the first quarter of 2017 and its label expansion is expected to boost sales further.

Zacks Rank

Amgen currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the healthcare sector include VIVUS, Inc. (NASDAQ:VVUS) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 in the last 60 days. The company delivered positive earnings surprises in all four trailing quarters with average beat of 233.69%.

Regeneron’s earnings estimates moved up from $10.16 to $10.52 for 2017 and from $10.90 to $12.10 for 2018, over the last 60 days. The company came up with positive earnings surprise in two of the last four quarters, with an average beat of 0.45%.

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