FDA modifies risk evaluation of Nplate

Amgen announced today that the FDA has agreed to modify the requirements of the Nplate® Risk Evaluation and Mitigation Strategy Program (REMS). When reviewing the restrictive elements of REMS, Amgen and the FDA have discovered that Nplate® cannot be directly linked to adverse events. As of December 7, 2011, patents, prescribing physicans, and institutions no longer need to enroll in the safety program called the Nplate® Network of Experts Understanding and Supporting Nplate® and Patients (Nplate® NEXUS) Program. This program was created to inform physicians and patients about the different effects of the Nplate®. Information will continue to be obtained from already enrolled patients until January 5, 2012.

SOURCE: Amgen Press Release