A day after announcing that it had suspended three rosiglitazone-containing anti-diabetes medications, the European Medicines Agency said Sept. 24 that it had refused a marketing authorization for cladribine (Movectro, Merck), an oral medicine intended to treat multiple sclerosis, and suspended Octagam, an intravenous human normal immunoglobulin solution.
Cladribine, originally developed as a leukemia treatment, was intended for use in MS patients with high disease activity or who could not tolerate the drugs beta-interferon or glatiramer acetate. EMA cited safety concerns in its decision against cladribine, saying “an increased number of patients with cancer were observed” during trials enrolling MS patients.
This, the agency said, “may indicate an increased risk of cancer over time and with increasing doses.” In July, oral cladribine was approved for relapsing-remitting MS in Russia; U.S. regulators have not yet ruled on cladribine for MS.
For Octagam, a medicine containing human normal immunoglobulin, the EMA moved to suspend all formulations of the medicine in all EU member states, with a recall effective immediately.
The recommendation, which, as with all EMA recommendations, awaits European Commission approval, came after German and Swedish regulators reported an increased risk of thromboembolic reactions linked to Octagam, the EMA said. German and Swedish officials suspended Octagam’s national marketing authorizations and recalled batches this month following reports of stroke, myocardial infarction, and pulmonary embolism in patients taking the medicine.
The problem is thought to be related to problems with Octagam’s manufacturing process, the EMA said in a news release Friday, and the suspension “will remain in place until the marketing authorization holder has rectified the problem.”
Octagam, an intravenous medication, is manufactured by Octapharma AG of Switzerland in 5% and 10% concentrations of its active ingredient, human normal immunoglobulin. Immunoglobulins are blood products used to strengthen the body’s immune system to lower the risk of infection in patients with immune disorders.
Meanwhile Sept. 24, the EMA announced that it had recommended marketing authorizations for three new medicines:
• Aflunov and Prepandemic (Novartis), an inactivated, adjuvanted prepandemic influenza vaccine containing antigens against the H5N1 subtype of influenza A.
• Ticagrelor (Brilique and Possia, AstraZeneca), a medication intended, in co-administration with acetylsalicylic acid, for the prevention of atherothrombotic events in adult patients with acute coronary syndromes.
• Tobramycin, (TOBI Podhaler, Novartis), an orphan medicine intended for the suppressive therapy of chronic pulmonary infection caused by Pseudomonas aeruginosa in adults and children 6 years and older with cystic fibrosis.
The agency also approved extensions of indication for two authorized medications:
• Rituximab (MabThera, Roche) to include the treatment of follicular lymphoma patients responding to induction therapy.
• Nilotinib (Tasigna, Novartis) to include the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia in the chronic phase.
Finally Sept, 24, the EMA said that it had commenced a risk-benefit review on bevacizumab (Avastin, Roche) a breast cancer treatment used in combination with anthracycline-based or capecitabine cytotoxic chemotherapy. The review, EMA said, was undertaken in a response to concerns about inconsistencies in effectiveness findings between different trials used to support Avastin’s current breast cancer indication.
The agency also initiated a risk-benefit review of medicines containing bisphosphonates to examine the possible increased risk of atypical stress fractures in patients taking the medicines for the treatment and prevention of osteoporosis and other bone disorders.
And EMA said that it would continue its review of a link between the pandemic influenza A (H1N1) vaccine Pandemrix (GlaxoSmithKline) and reports of narcolepsy; however, the agency’s reviewers had identified only 81 possible cases reported to it by health professionals and 13 additional consumer reports. Some 30.8 million Europeans have been inoculated with Pandemrix over the past year. The results of the Pandemrix review will be available within three to six months, the agency said.
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在宣布暂停使用三种含罗格列酮的抗糖尿病药物后，欧洲药品管理局（European Medicines Agency，EMA）拒绝了口服治疗多发性硬化症药物克拉屈滨（Movectro，默克公司生产）的上市许可，并暂停使用人体静脉注射用免疫球蛋白Octagam。
克拉屈滨最初是作为白血病治疗药物而得以开发，旨在用于重度或不能耐受β干扰素或醋酸格拉默的多发性硬化症患者。EMA表示其暂停使用克拉屈滨的决定是出于安全性考虑，因为在招募到的多发性硬化症患者中，已有越来越多的患者罹患癌症，而且有迹象表明随着时间推移以及剂量的增加，患者罹患癌症风险增加。在7月，俄罗斯批准将口服克拉屈滨用于治疗复发好转型多发性硬化症；而美国当局仍未将克拉屈滨用于治疗多发性硬化症。
Octagam是一种含人正常免疫球蛋白的静脉用药，由瑞士Octapharma AG公司生产，含5％和10％浓度的活性成分人体正常免疫球蛋白。该免疫球蛋白是血液制品，用来加强人体的免疫系统，从而降低免疫系统疾病患者的感染危险。
EMA在所有欧盟成员国暂停使用该药的所有剂型，且该召回立即生效；同时称，德国和瑞典监管机构报告称Octagam存在增加血栓风险，暂停了Octagam的全国上市许可，并在本月依次报告发现使用该药的患者有致卒中、心肌梗死和肺栓塞风险后，将该药的所有批次全部集体召回。EMA表示，该暂停令“将一直有效，直至上市许可持有者纠正其存在的问题”。
EMA在9月24日宣布推荐3种新药的上市许可：
•Aflunov和Prepandemic（诺华制药公司生产），一种灭活、含有甲型流感病毒亚型H5N1抗原的大流行前流感疫苗。
•替格雷洛（Brilique和Possia，阿斯利康制药公司生产），一种与乙酰水杨酸共同用于预防急性冠脉综合征患者的动脉粥样硬化事件的药物。
•妥布霉素（TOBI Podhaler，诺华制药公司生产），一种用于成年患者慢性肺绿脓假单胞菌感染的抑菌药和6岁以上纤维囊泡症患者的孤儿药。
EMA还批准了两种授权药物的扩展适应证：
•利妥昔单抗（MabThera，罗氏制药），用于滤泡性淋巴瘤患者的诱导治疗。
•尼洛（Tasigna，诺华制药），用于新诊断出费氏染色体阳性的慢性髓细胞性白血病患者的慢性期治疗。
9月24日，EMA表示开始对贝伐单抗（Avastin，罗氏制药生产）进行风险效益评估，旨在检验不同临床试验间该药有效性结果与Avastin当前乳腺癌适应证不一致的情况；并且还将开展含双膦酸盐药物的风险效益评估，旨在检查非典型应力性骨折患者使用该药治疗和预防骨质疏松症和其他骨功能障碍时可能存在的风险。EMA同时表示当局将继续评估甲型流感病毒（H1N1）疫苗Pandemrix（葛兰素史克）与嗜睡症之间的相关性，其评估结果将在未来3~6个月获得。
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