Decision Resources, a research and advisory firm for pharmaceutical and healthcareissues, finds that, despite the U.S. Food and Drug Administration’s (FDA)recent request for postmarketing surveillance of Amgen’s Prolia, the drug’sexpected launch this year in the United States and Europe for the treatment ofosteoporosis 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 raisedconcerns about an increased risk for infections and malignancy observed inPhase III clinical trials for Prolia. “This additional requirement of surveillance will likely preventphysicians from prescribing Prolia until the drug’s long-term safety can beverified,” said Decision Resources Analyst Matthew Scutcher, Ph.D. “Althoughthis will result in a slower rise in the drug’s uptake than initiallyexpected, Prolia will still garner robust sales of $1.1 billion in 2018 in theworld’s major markets.” The recent recommendation by the Committee for Medicinal Products forHuman Use (CHMP) to the European Medicines Agency to approve Prolia hascleared the path for the agent’s expected launch in Europe in 2010. InDecember 2009, the CHMP recommended the approval of Prolia for the treatmentof osteoporosis in women who are at increased risk of bone fracture.