FDA eases REMS requirements for Amgen's Nplate and GSK's Promacta

The US Food and Drug Administration says that an agency initiated review of the current information has determined that, while safety risks for both US biotech firm Amgen’s (Nasdaq: AMGN) Nplate (romiplostim) and UK pharma giant GlaxoSmithKline’s (LSE: GSK) and Promacta (eltrombopag) still exist, certain restrictive requirements of the Risk Evaluation and Mitigation Strategies (REMS) programs are no longer necessary to ensure that the benefits of the drugs outweigh their risks. Nevertheless, the FDA will continue to monitor these drugs, used for the treatment of idiopathic thrombocytopenia, for safety risks.

The agency has concluded that the long-term safety of Nplate and Promacta can be evaluated based on ongoing clinical trials, post-approval studies agreed to by both companies and adverse event reports submitted to the FDA.

Major changes to the REMS for both products include: