Amgen files sBLA for Nplate in adult ITP.- Amgen.

Amgen announced the submission of a Supplemental Biologics License Application (sBLA) to the FDA for Nplate (romiplostim) to include the treatment of adult patients with immune thrombocytopenia (ITP) who have had ITP for 12 months or less and an insufficient response to corticosteroids, immunoglobulins or splenectomy.

The submission is supported by nine studies evaluating the safety and efficacy of Nplate in adults with ITP, including two long-term open-label extension studies. Expansion of the indication for Nplate to include adult patients with ITP for 12 months or less is supported by data from 311 patients who were diagnosed with ITP within 12 months prior to study enrollment.