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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