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【drug-news】FDA批准安进公司血小板增生新药
The injectable drug helps stimulate bone marrow into producing blood platelets in patients with chronic immune thrombocytopenic purpura (ITP), the FDA said. The agency approved its use for patients only after other available treatments fail to help.
"This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," said Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research.
Other approved ITP treatments include steroids, immune-suppressing drugs or surgery to remove the spleen.
"Until now there have been limited FDA-approved treatments available to patients suffering from chronic adult ITP, and the treatment options were often unsuccessful for long-term use," Amgen said in a statement.
The total cost of care for Nplate patients is expected to be "less than or comparable to the total costs of care with standard treatment regimens," the Thousand Oaks, California-based biotech company said.
Nplate was approved based on two studies of 125 patients who took the drug for six months, according to the FDA. Doctors who want to prescribe Nplate will have to enroll themselves and their patients into a special registry that will track long-term safety.
Those who received Nplate showed "significantly higher platelet counts and maintained those higher counts compared to those who did not receive the drug," the FDA said. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 WASHINGTON (Reuters) - Amgen Inc drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the Food and Drug Administration said on Friday in approving the product for U.S. sales.
华盛顿（路透社消息）-星期五美国食品药品管理局宣布，安进公司的药物Nplate对治疗一种罕见的血小板失调病是安全有效的，因此批准其在美国上市销售。
The injectable drug helps stimulate bone marrow into producing blood platelets in patients with chronic immune thrombocytopenic purpura (ITP), the FDA said. The agency approved its use for patients only after other available treatments fail to help.
FDA称，该注射剂有助于刺激那些患有慢性免疫性血小板减少性紫癜病患者体内的骨髓制造血小板。药品审批部门批准这个药物只能在其他现有的治疗措施无效之后使用。
"This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," said Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research.
FDA药品评估和研发中心的主管--珍妮特·伍德考克博士认为，这个药物的重要性在于它为治疗这种罕见的血液失调病提供了一个新途径，而这些患者通常身体十分虚弱。
Other approved ITP treatments include steroids, immune-suppressing drugs or surgery to remove the spleen.
其他被认可的治疗免疫性血小板减少性紫癜病的手段包括：甾体类药物，免疫抑制剂类药物，或者通过外科手术切除患者的脾脏。
"Until now there have been limited FDA-approved treatments available to patients suffering from chronic adult ITP, and the treatment options were often unsuccessful for long-term use," Amgen said in a statement.
安进公司在该药物的声明中写到，截止到目前，针对成人慢性免疫性血小板减少性紫癜病患者尚无一种不受限制的药物通过FDA审核批准，而且现在已有的治疗方案通常在长期的治疗过程中并不奏效。
The total cost of care for Nplate patients is expected to be "less than or comparable to the total costs of care with standard treatment regimens," the Thousand Oaks, California-based biotech company said.
来自加州的千橡生物技术公司的观点认为，患者使用Nplate治疗该疾病的花费预计少于或者和标准的治疗方案不相上下。
Nplate was approved based on two studies of 125 patients who took the drug for six months, according to the FDA. Doctors who want to prescribe Nplate will have to enroll themselves and their patients into a special registry that will track long-term safety.
根据FDA的标准，Nplate在进行了两次临床实验的基础上获审批通过，每次实验125名患者服用该药物6个月。处方中如果需要开这个药的医生必须注册申请，同时其患者也要做一个特殊的登记入册，以便跟踪其今后长期的药物安全性情况。
Those who received Nplate showed "significantly higher platelet counts and maintained those higher counts compared to those who did not receive the drug," the FDA said.
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作者:admin@医学,生命科学 2010-12-02 17:11
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