FDA modifies REMS for 2 platelet-booster drugs

February 1, 2012

In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).

In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).

"An FDA-initiated review of the current information has determined that while safety risks for both Nplate and Promacta still exist, certain restrictive requirements of the REMS programs are no longer necessary to ensure that the benefits of the drugs outweigh their risks," FDA said.

Nplate and Promacta were both approved in 2008 for the treatment of chronic immune thrombocytopenia (ITP) in adults who have not responded to corticosteroids, immunoglobulins, or to the removal of their spleen (splenectomy).

ESTABLISH LONG-TERM SAFETY THROUGH ONGOING TRIALS

However, because the underlying medical conditions in patients with chronic ITP made the safety data collected by the REMS programs difficult to interpret, FDA has determined that the safety data collection requirements are not informative and are no longer necessary for that purpose.

Rather, FDA concluded that long-term safety is best established through ongoing clinical trials, post-approval studies, and post-marketing adverse event reports.

Changes to the REMS state that healthcare professionals, hospitals, specialty-care facilities, and patients are no longer required to be enrolled in the Nplate NEXUS Program or the Promacta CARES Program to prescribe, dispense, or receive these products.

Healthcare professionals also will no longer be required to complete periodic safety forms for patients receiving these drugs.

Pharmacies and pharmacists no longer are required to enroll in the Promacta CARES Program or verify prescriber and patient enrollment before dispensing Promacta.

The modified REMS programs will include a communication plan that will inform healthcare professionals about the changes to the REMS and the safety risks associated with each product, according to FDA.

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