FDA modifies REMS for two drugs to treat low platelet counts
SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.
The Food and Drug Administration announced changes to the REMS programs for Amgen's Nplate (romiplostim) and GlaxoSmithKline's Promacta (eltrombopag), two drugs approved in 2008 to treat low platelet counts in patients with chronic immune thrombocytopenia, who have not responded to other drugs or to the removal of their spleens. In addition, pharmacists will no longer have to enroll in the Promacta CARES safety monitoring program or verify prescriber and patient enrollment to dispense the drug. Meanwhile, both drugs' REMS programs will include a communication plan to inform healthcare professionals about the changes and the drugs' safety risks.
The FDA said that some of the requirements of the drugs' REMS programs were no longer necessary to ensure that their benefits outweighed their risks.
"REMS continue to be vital tools for the agency to employ as we work with companies to address the serious risks associated with drugs and monitor their appropriate and safe use in various healthcare settings," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "The agency remains committed to exercising a flexible and responsible regulatory approach that ensures REMS programs are being effectively and efficiently used and not resulting in an unnecessary burden on healthcare professionals and patients."