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Amgen Label Expansion Application for Prolia Accepted by FDA

Zacks

Amgen, Inc. AMGN announced that the FDA has accepted its regulatory application in the United States seeking label expansion for Prolia for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The FDA is expected to give its decision on May 28 next year.

Prolia 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.

The supplemental Biologics License Application (sBLA) was submitted in July this year. The sBLA was based on a phase III study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid medications.

GIOP 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 beginning treatment. Prolia, if approved for the treatment of GIOP, can 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 international markets. In the first half of 2017, the drug generated sales of $930 million, up 17% year over year.

Amgen’s shares have rallied 26.9% this year so far, better than the industry’s growth of 14.1% so far this year.

Currently, Amgen holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Key Picks

Some other top-ranked biotech stocks include Vertex Pharmaceuticals Incorporated VRTX, PDL BioPharma, Inc. PDLI and Celgene Corporation CELG. While Vertex and PDL BioPharma sport a Zacks Rank #1 (Strong Buy), Celgene has the same Zacks Rank as Amgen.

Vertex has witnessed the Zacks Consensus Estimate for current-year earnings climb 1.8% for 2017 and 6.8% for 2018 over the past 90 days. The company’s shares have increased 111.2% this year so far.

PDL BioPharma’s earnings estimates have gone up by 263% for 2017 and 174% for 2018. Its shares have risen 60.4% this year so far.

Celgene’s earnings estimates for 2017 inched up 0.7% while that for 2018 went up by 1.1% in the past 90 days. The stock has rallied 20.4% so far this year, outperforming the industry.

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