Despite FDA Recommendation for Postmarketing Surveillance, Amgen's Prolia Will Achieve Blockbuster Sales for Treatment of Osteoporosis
Prolia's Uptake Will Likely be Tempered Until Long-Term Safety is Verified, According to New Findings from Decision Resources
WALTHAM, Mass., Jan. 7 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, despite the U.S. Food and Drug Administration's (FDA) recent request for postmarketing surveillance of Amgen's Prolia, the drug's expected launch this year in the United States and Europe for the treatment of osteoporosis will drive Prolia to garner blockbuster sales in 2018..
The Pharmacor finding from the topic entitled Osteoporosis reveals that, while regulatory approval for Prolia in the European Union appears imminent, the FDA has recommended postmarketing surveillance of the agent in the U.S., owing to safety concerns. Late last year, an FDA advisory committee raised concerns about an increased risk for infections and malignancy observed in Phase III clinical trials for Prolia.
"This additional requirement of surveillance will likely prevent physicians from prescribing Prolia until the drug's long-term safety can be verified," said Decision Resources Analyst Matthew Scutcher, Ph.D. "Although this will result in a slower rise in the drug's uptake than initially expected, Prolia will still garner robust sales of $1.1 billion in 2018 in the world's major markets."
The recent recommendation by the Committee for Medicinal Products for Human Use (CHMP) to the European Medicines Agency to approve Prolia has cleared the path for the agent's expected launch in Europe in 2010. In December 2009, the CHMP recommended the approval of Prolia for the treatment of osteoporosis in women who are at increased risk of bone fracture.
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About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.
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For more information, contact:
Decision Resources Decision Resources, Inc.
Christopher Comfort Elizabeth Marshall
781-296-2597 781-296-2563
[email protected] [email protected]
SOURCE Decision Resources
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