ST LOUIS (MD Consult) - On August 17, 2009, Novartis announced that the US Food and Drug Adminsitration has approved Extavia for the treatment of relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging. Extavia, a new branded version of interferon beta-1b, is the same medicinal product as Betaseron.
Extavia will be available to patients in the United States in the fall of 2009. Along with their prescription for Extavia, Novartis will be giving patients access to a support program that includes a nurse helpline, one-on-one injection training, and reimbursement support services. In addition, the manufacturer will make an autoinjector available to patients taking Extavia.
According to a press release by Novartis, treatment with interferon beta-1b has been shown to reduce annualized MS relapse rates by 34% (P = .0001), with patients who are taking the drug nearly twice as likely to remain relapse-free for more than 2 years compared with patients receiving placebo (31% vs 16%, P = .007). In addition, treatment with interferon beta-1b may slow disease progression. In studies, after 2 years, almost 75% of patients who experienced a single episode of neurologic disease of ≥ 24-hours' duration did not progress to experience clinically evident MS.
圣路易斯(MD Consult)——2009年8月17日,诺华公司宣布,美国食品药品管理局(FDA)已经批准Extavia用于治疗复发性多发性硬化症(MS),减少其临床病情恶化次数。这项治疗同样也适用于经历过MS首次临床发作且磁共振成像(MRI)所示的特征表现与MS相符的患者。Extavia是β-1b重组干扰素的新商品名,与Betaseron属同类药品。
诺华公司拟于2009年秋季在美国市场推出Extavia。患者除了可通过处方获得Extavia外,诺华公司还将为患者提供支持服务,其中包括开通护理咨询热线,一对一药物注射培训,以及医保报销指导服务。此外,生产厂家将提供自动注射器,以便于患者自行注射Extavia。
据诺华公司召开的新闻发布会宣称,研究表明,β-1b重组干扰素治疗可使MS的年复发率降低34% (P =0.0001),服用Extavia的患者中未出现复发的人数几乎为安慰剂对照组的2倍(31% 对 16%, P =0.007)。另外,β-1b重组干扰素可延缓病程的进展。在研究中,在经历过单次神经系统疾病发作且病程≥ 24h的患者中有近75%在2年之后未进展至有临床表现的MS。
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