The US Food and Drug Administration announces changes to risk strategy requirements for two drugs to treat low platelet counts.
The drugs in question are Amgen's Nplate (romiplostim) and GlaxoSmithKline's Promacta (eltrombopag) and the agency has approved changes to the risk evaluation and mitigation strategies for the treatments. The FDA has decided that "certain restrictive requirements of the REMS programmes are no longer necessary to ensure that the benefits of the drugs outweigh their risks".
The principal change is that prescribing doctors, patients and institutions are no longer required to enroll in Amgen's and GSK's respective safety monitoring programmes, Also doctors will not have to complete periodic safety forms for patients receiving Nplate or Promacta.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said that “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 health care settings". She added that the agency "remains committed to exercising a flexible and responsible regulatory approach that ensures REMS programmes are being effectively and efficiently used and not resulting in an unnecessary burden on health care professionals and patients.”
Nplate and Promacta were both approved in 2008 to treat adults with chronic immune thrombocytopenia (ITP), who have not responded adequately to corticosteroids, immunoglobulins or to the removal of their spleen. ITP is a rare blood disorder that results in a low number of platelets, which can lead to serious bleeding.