Amgen公司用于治疗罕见血凝异常疾病的药物Nplate已在欧洲通过批准，这使得该公司抢得先机，比GSK/ Ligand两家公司的同类药品Promacta更早进入欧洲市场。 

    欧盟委员会批准Nplate用于治疗那些对目前常用药无应答的免疫性血小板减少性紫癜（ITP），但它仅获准作为二线药物用于那些未进行脾脏切除，且不适宜接受手术治疗的成人ITP患者。

    这次Nplate在欧洲获准的依据是两项III期临床实验，结果证实进行过或未进行过脾脏切除手术的患者用药治疗之后，他们体内的血小板读数均升高83%，并且保持稳定。有医务人员表示，Nplate是第一种在欧洲获准特别针对提高患者体内血小板数量，并且能长期使用的ITP治疗药。

    虽然患有ITP的人数量不多，据估计在欧洲有5万慢性ITP患者，但这种病症会极大地影响他们的生活，而Nplate可以为他们带来福音。

    Amgen公司负责人表示，此次Nplate在欧洲获准是该公司15年来辛勤努力的结果，同时作为第一种获准的肽体类药，它在该公司生物制剂的开发上也具有里程碑意义。去年2008年8月份Nplate已在美国获准。

NPLATE

Indications for NPLATE

Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Adult dose for NPLATE

Give by SC inj. To reduce risk of bleeding: use lowest effective dose to achieve and maintain platelets ≥50x10⁹/L. ≥18yrs: initially: 1mcg/kg weekly; may increase by 1mcg/kg if platelets <50x10⁹/L; max: 10mcg/kg weekly. May reduce by 1mcg/kg if platelets >200x10⁹/L for 2 consecutive weeks. Do not dose if platelets >400x10⁹/L; resume Nplate at a dose reduced by 1mcg/kg when platelets fall to <200x10⁹/L. Discontinue if platelets have not increased after 4 weeks at max dose.

Children's dosing for NPLATE

<18yrs: not recommended.

Warnings/Precautions for NPLATE

Not for normalization of platelet counts. Risk of bone marrow fibrosis with cytopenias. Worsened thrombocytopenia after discontinuation. Monitor CBCs, platelets, and peripheral blood smears before and weekly during dose adjustments then monthly after achieving stable dose; and weekly for 2 weeks after discontinuation of therapy. Monitor after initial response for formation of neutralizing antibodies. Risk of hematologic malignancies (esp. myelodysplastic syndrome). Renal or hepatic impairment. Elderly. Pregnancy (Cat.C). Nursing mothers.

Interactions for NPLATE

May increase bleeding risk with anticoagulants or antiplatelet agents.

Adverse Reactions for NPLATE

Arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, paresthesia, headaches; bone marrow reticulin deposition, worsening thrombocytopenia, risk of bleeding, thrombotic/thromboembolic complications, antibody formation.

Notes for NPLATE

Available only through Nplate NEXUS program. To register for Nplate NEXUS program or for pregnancy registry call Amgen at (877) Nplate1.

How is NPLATE supplied?

Single-use vial—1