![]() The FDA based its decision on the results of the same clinical trials that influenced the EMA’s recommendation. “The anticoagulant effects of are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary,” he says. The FDA’s director of the Office of Hematology and Oncology Products in its Center for Drug Evaluation and Research, Richard Pazdur, says the approval of idarucizumab offers clinicians an “important tool” for managing patients taking dabigatran in emergency or life-threatening situations when bleeding cannot be controlled. The decision by the Food and Drug Administration (FDA) comes three weeks after a similar recommendation by the European Medicines Agency (EMA) - the body responsible for approving the licensing of drugs across the European Union. The US medicines safety watchdog has given fast-track approval to idarucizumab (Praxbind), a drug that can neutralise the effects of the anticoagulant dabigatran etexilate (Pradaxa). Journal of Pharmaceutical Health Services Research.International Journal of Pharmacy Practice. ![]() Antimicrobial resistance and stewardship. ![]()
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