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- W96548806 abstract "When the U.S. Food and Drug Administration’s Arthritis Advisory Committee turned its spotlight on Bristol-Myers Squibb’s Orencia (abatacept) in early September, it was the drug developer’s follow-up safety review plan that helped to persuade the committee to recommend approval of the rheumatoid arthritis treatment.The FDA had been concerned about the possibility of the therapy being associated with an increased risk of malignancy and infections. Also, when used in conjunction with a biologic such as a tumor necrosis factor inhibitor, patients in BMS’s clinical program had demonstrated an increase in infections.But BMS had a well-defined postmarketing risk-assessment plan in place: Recommend against concomitant use with other biologics and monitor the real-world effects of the drug through evaluation of spontaneous adverse-event reports and two pharma-coepidemiologic studies. One study will compare long-term outcomes of 5,000 abatacept-treated patients with the experiences of 15,000 people on other RA medications. The other will use a robust database of de-identified, real-world healthcare experiences of more than 11 million patients from Ingenix, a UnitedHealth Group subsidiary, and will also compare outcomes of patients treated with abatacept versus those on other RA drugs.Bristol-Myers Squibb walked away with a unanimous recommendation for approval. That was the payoff for careful attention to a detailed pharmacovigilance program.“It’s more than a trend; it’s becoming the norm. And, in that sense, it’s a new standard that companies have to live up to,” says John Balian, MD, BMS’s vice president of global pharmacovigilance and epidemiology. “In essence, all applications should contain a risk-management plan. This plan is considered as seriously as the rest of the submission. Regulators are looking to pharmacovigilance plans to see what kind of monitoring systems or analytical processes and systems we’re putting in place once we put a drug on the market.”" @default.
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- W96548806 date "2005-12-01" @default.
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- W96548806 title "Pharmacovigilance: the new drug-development standard." @default.
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