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Nplate(TM) (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union
Date:11/21/2008

ut Nplate

Nplate was granted approval for ITP by the regulatory bodies in Australia in July and the United States (U.S.) in August 2008. In addition to the European Union (EU), Amgen has filed for regulatory approval of Nplate in Canada and Switzerland and these applications are currently under review. Nplate has also received orphan designation for ITP in the U.S. (2003), the EU (2005), Switzerland (2005) and Japan (2006).

Nplate is the first treatment specifically developed for ITP. It is also being investigated for potential use in pediatric ITP, myelodysplastic syndrome (MDS) and chemotherapy-induced thrombocytopenia (CIT).

Important EU Nplate Safety Information

The most common side effects are headache, fatigue, arthralgia, myalgia, injection site bruising, injection site pain, oedema peripheral, dizziness, muscle spasms, nausea, contusion, diarrhea, bone marrow disorder, influenza like illness, insomnia and pruritus.

Reoccurrence of thrombocytopenia and bleeding after cessation of treatment and increased bone marrow reticulin have been associated with romiplostim treatment in the clinical trials. Thrombotic/thromboembolic complications, progression of existing haematopoietic malignancies or Myelodysplastic Syndromes (MDS), and effects on red and white blood cells are all potential risks associated with romiplostim treatment. As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein.

Important U.S. Nplate Safety Information

Serious adverse reactions associated with Nplate in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation. Additional risks include bone marrow fibrosis, thrombotic/thromboembolic complications, lack or loss of response to Nplate, and hematological malignancies and progression of malignancy in patients with a pre-existing hem
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SOURCE Amgen
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