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The FDA on Tuesday announced that it modified the requirements of the Risk Evaluation and Mitigation Strategy (REMS) for Amgen’s Nplate (romiplostim) and GlaxoSmithKline’s Promacta (eltrombopag) so that prescribers and patients are no longer required to enroll in the safety monitoring programme for the drug. In addition, healthcare professionals will no longer be required to complete periodic safety checks for patients receiving either chronic immune thrombocytopenic purpura (ITP) therapy.

Since the approval of Nplate and Promacta, the FDA has continued to monitor specific safety risks related to both products including bone marrow changes of collagen deposition, higher risk for venous thromboembolism and increased risk of development of other hematological malignancies. The agency noted that Promacta may also cause liver injury.

Amgen executive vice president of R&D Roger M. Perlmutter noted that "Amgen will continue to monitor the safety profile of Nplate through clinical trials and post-marketing pharmacovigilance programmes."

Nplate and Promacta garnered approval in 2008 to treat adult patients with chronic ITP who have not responded adequately to corticosteroids, immunoglobulins or splenectomy.

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