Amgen announced the U.S. Food and Drug Administration (FDA) has modified the requirements of the Nplate (romiplostim) Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribing physicians, patients and institutions are no longer required to enroll in the safety monitoring program, called the Nplate NEXUS (Network of EXperts Understanding and Supporting Nplate and Patients) Program, in order to prescribe or receive Nplate.
“The goals of the Nplate NEXUS Program were to educate physicians and patients about treatment risks and benefits, and to define the long-term safety profile of Nplate,” said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. “The FDA has now concluded that enrollment in a restricted distribution program is no longer necessary to prescribe or receive Nplate. Amgen will continue to monitor the safety profile of Nplate through clinical trials and post-marketing pharmacovigilance programs.”
The primary modification of the REMS is the removal of the elements to assure safe use; however, a modified REMS communication plan will remain in place. In addition, the Medication Guide will no longer be part of the REMS, but will be part of approved product labeling.
From 2008 to 2011, the Nplate NEXUS Program has collected long-term safety data from more than 5,200 patients. The restrictive elements of the REMS included enrollment of prescribers, patients, and institutions to assist in collecting long-term safety information. Upon further review, the FDA and Amgen have determined that the safety information collected through the REMS, which is based on individual case safety reports, is inherently confounded by underlying medical conditions in the treated patient population and thus cannot be used to determine the precise role of Nplate in the development of the adverse events. Based in part on this determination, and the data submitted from clinical trials, the FDA and Amgen have concluded that the restricted elements of the REMS can be eliminated. For this reason enrollment of prescribers, patients and institutions and mandatory collection of safety data is no longer required.
As of Dec. 7, 2011, prescribing physicians and institutions will be able to order Nplate without enrolling themselves or patients in the Nplate NEXUS Program. The program will continue to obtain information from already enrolled patients through Jan. 5, 2012, and Nplate NEXUS Program support assistance will continue for 28 days after approval of the modified REMS.
Date: December 6, 2011