Amgen's Label Expansion Application For Prolia Gets FDA Nod

Amgen, Inc. (NASDAQ:AMGN) announced that the FDA has approved its supplemental Biologics License Application (sBLA) seeking label expansion for Prolia for the treatment glucocorticoid-induced osteoporosis (“GIOP”) in men and women at high risk of fracture or those who have failed or are intolerant to other available osteoporosis therapy.

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

The drug is presently marketed in the United States for the treatment of postmenopausal women with osteoporosis at high risk for fracture as well as to increase bone mass in men with osteoporosis at high risk for fracture.

Shares of Amgen were up 0.1% in after-market trading following the news. The company’s shares have rallied 1.5% this year so far against the industry’s decline of 9.8%.

The phase III study evaluated Prolia for the treatment of GIOP patients in men and women at high risk of fracture or those who have failed or are intolerant to other available osteoporosis therapy compared to Allergan’s (NYSE:AGN) Actonel (risedronate). The study comprises two patient groups – one with patients who have received glucocorticoid treatment for less than three months prior to study enrollment (glucocorticoid-initiating arm) and the second with patients who have received glucocorticoid treatment for at least three months (glucocorticoid-continuing arm). In both the arms, the glucocorticoid treatment was continued for at least six months.

Data from the study showed that Prolia increased lumbar spine BMD by 3.8% compared with 0.8% by Actonel in glucocorticoid-initiating arm. Lumbar spine BMD in patients treated with Prolia in glucocorticoid-continuing arm increased 4.4% compared with 2.3% for Actonel.

Glucocorticoid-induced osteoporosis is the most common form of secondary osteoporosis. This serious condition is presently treated with glucocorticoid treatment, which increases fracture risk within the first three months of treatment. Prolia can now cater to an expanded patient population and drive sales higher.

Prolia is a key revenue generator for Amgen and is witnessing market share gains in both the United States and internationally amid competition from generics of other drugs approved for osteoporosis. In 2017, the drug generated sales of $1.97 billion, up 20% year over year.

Prolia faces competition from several drugs, especially from generic versions of Eli Lilly’s (NYSE:LLY) Evista (alendronate), Merck’s (NYSE:MRK) Fosamax (raloxifene) and Novartis’ Zometa (zoledronate).

Amgen Inc. Price

Amgen Inc. Price | Amgen Inc. Quote

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.

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 >>