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12:00 AM
 | 
Mar 17, 2008
 |  BioCentury  |  Regulation

Nplate a template

Regulation

Nplate a template

Despite seeing good efficacy and adverse events little different than placebo, FDAindicated last week that approval of Amgen Inc.'s Nplate romiplostim for idiopathic thrombocytopenic purpura will require stringent monitoring of patients.

Last week, FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend approval of the BLA for Nplate to treat thrombocytopenia (low platelet counts) in adults with chronic ITP.

The consensus was that Nplate provides a much needed alternative to the current standard of care, which tends to follow the sequence of steroids, immune globulin infusion, other rescue agents and ultimately splenectomy (see "Nplate Efficacy").

Nplate is a recombinant fusion protein that combines a human IgG Fc domain linked to two thrombopoietin receptor binding domains. Coined a "peptibody" by Amgen, Nplate binds to the TPO receptor to increase the production of platelets and reduce the risk of bleeding faced by these patients.

The focus is now on safety because of the small number of patients in the clinical trial program. As a result, FDA said patients with a confirmed diagnosis of ITP would have to be registered into a safety database and have failed at least one prior treatment before a hematologist could prescribe Nplate.

These restrictions and procedures could potentially tie the hands of physicians because ITP poses serious risk of bleeding-related disorders, and there may not be enough time to get a patient having an acute bleeding event registered and approved for Nplate.

Amgen agreed to institute a risk minimization action plan (RiskMAP) that would include targeted education of prescribing hematologists and oncologists, limiting access...

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