聚乙二醇干扰素β-1a获准用于复发性MS治疗

百键艾迪公司8月15日宣布，基于ADVANCE试验结果，该公司生产的聚乙二醇干扰素β-1a已获得美国食品药品管理局（FDA）批准，用于治疗复发性多发性硬化症（MS）。

据该公司声明，这是获准用于治疗复发性MS的唯一聚乙二醇干扰素。

声明指出，该公司将以商品名Plegridy上市该药物。推荐剂量为每14天皮下注射125 μg，可采用预装药品注射器或该公司新上市的自助注射器（Plegridy 笔）给药。

该批准令是基于ADVANCE研究结果。该研究是一项纳入约1,516例复发性MS患者的为期2年的随机、双盲III期临床试验，第一年采取安慰剂对照。与安慰剂组相比，聚乙二醇干扰素β-1a治疗组年复发率（主要结局）降低36%，具有显著性差异。

在次要结局方面，与安慰剂组相比，治疗组复发患者比例下降19%，新增或新增大T2高信号病灶数量减少67%，新增钆增强病灶平均数量减少86%。

据该药物处方信息，注射部位红斑、流感样疾病、发热、头疼、肌痛、寒颤、注射部位疼痛、乏力、注射部位瘙痒以及关节痛是与治疗相关的最常见不良事件，至少10%的治疗患者受累，发生率至少高于对照组2%。

要求该公司开展的上市后研究包括在美国进行一项儿科研究和一项登记研究，以比较孕期接受聚乙二醇干扰素β-1a治疗的MS女性患者与未接受治疗者以及非MS女性母体、胎儿和婴儿结局，包括出生缺陷。

该产品已在欧洲获准上市。

与该产品相关的严重不良事件应通过800-332-1088或www. fda.gov/medwatch报告至FDA。

By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

Peginterferon beta-1a has been approved by the Food and Drug Administration for treating relapsing forms of multiple sclerosis, based on the results of the ADVANCE trial, the manufacturer, Biogen Idec, announced on August 15.

This is the only pegylated interferon approved for treating relapsing MS, according to a statement from the company.

Biogen Idec will be marketing the drug as Plegridy. The recommended dose is 125 mcg administered subcutaneously every 14 days. It can be administered with a prefilled syringe or a new autoinjector the company is marketing as the Plegridy Pen, according to the statement.

The approval is based on the results of the ADVANCE study, a randomized, double-blind, phase III, 2-year study of about 1,516 patients with relapsing MS, which was placebo-controlled during the first year. The annualized relapse rate, the primary outcome, was reduced by 36% among those treated with peginterferon beta-1a, compared with those on placebo, a statistically significant difference.

Secondary outcomes including the proportion of patients who relapsed, which was reduced by 19%, compared with placebo; the mean number of new or newly enlarging T2 hyperintense lesions, which was reduced by 67%, compared with placebo; and the mean number of new gadolinium-enhancing lesions, which was reduced by 86%, compared with placebo.

Injection-site erythema, influenzalike illness, fever, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia were the most common adverse events associated with treatment, affecting at least 10% of treated patients and occurring at a rate that was at least 2% greater than among those on placebo, according to the prescribing information.

Postmarketing studies that the company will be required to conduct include a pediatric study and a registry study in the United States that will compare the maternal, fetal, and infant outcomes, including birth defects, of women with MS who are treated with peginterferon beta-1a during pregnancy against women with MS who are not treated with the drug during pregnancy and women who do not have MS.

The product has already been approved in Europe.

Serious adverse events associated with this product should be reported to the FDA at 800-332-1088 or www. fda.gov/medwatch.