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Amgen's (AMGN) Prolia Gets Label Expansion Approval in Europe

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Amgen (AMGN - Free Report) announced that the European Commission (“EC”) has approved label expansion of its blockbuster drug, Prolia. The drug is now approved for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. This is also called glucocorticoid-induced osteoporosis.

This is the third approved indication for Prolia in Europe. The approval is backed by increase in bone mineral density (“BMD”) achieved by the drug in a phase III study.

A similar line extension application received approval in the United States last month.

Prolia is presently marketed in Europe for the treatment of men and postmenopausal women with osteoporosis at high risk for fracture as well as to increase bone mass in men with prostate cancer receiving hormone ablation.

Amgen’s shares have increased 6% this year so far against the industry’s decline of 6.9%.


The phase III study evaluated Prolia for improvement in BMD in patients receiving glucocorticoid treatment, compared to Allergan’s (AGN - Free Report) Actonel (risedronate). The study comprises two patient groups – one with patients on sustained glucocorticoid treatment (glucocorticoid-continuing arm) and the second with patients initiating glucocorticoid therapy (glucocorticoid-initiating arm). In both arms, Prolia demonstrated greater improvement in lumbar spine BMD in patients at one year and two years compared to Actonel, the study’s primary endpoint.

Glucocorticoid-induced osteoporosis is the most common form of secondary osteoporosis. Per the press release, 30% to 40% of the patients receiving glucocorticoid treatment for the long term have shown vertebral fractures. Although the proportion of eligible patients is small, this line extension is likely to boost sales of the drug further.

Prolia is one of the major revenue sources for Amgen and is witnessing growth in market share in both the United States and internationally amid competition from generics of other drugs approved for osteoporosis. In the first quarter of 2018, the drug generated sales of almost half a billion dollars, up 16.5% year over year.

The drug faces competition from generics of other branded drugs including Eli Lilly’s (LLY - Free Report) Evista (alendronate), Merck’s (MRK - Free Report) Fosamax (raloxifene) and Novartis’ Zometa (zoledronate).

Zacks Rank

Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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