The European Medicines Agency has recommended marketing authorizations for a host of new drugs and approved extensions of indication for others—including the diabetes drug exenatide and a quadrivalent vaccine against human papilloma virus.
At its monthly meeting, the agency’s Committee for Medicinal Products for Human Use approved an extension of indication for exenatide to include its use in combination with thiazolidinediones. Exenatide (Byetta, Eli Lilly) already has E.U. marketing authorization for use in triple-therapy regimens for type 2 diabetes in combination with metformin and a thiazolidinedione. The extension would allow its use in dual therapy regimens with thiazolidinediones, the agency announced June 25.
EMA recommended also that the marketing authorization for the quadrivalent human papillomavirus vaccine marketed as Gardasil (Sanofi Pasteur) and Silgard (Merck), meant to prevent genital lesions, genital warts, and cervical cancer, be extended to include use in women up to 45 years old. The vaccine had initially been authorized for use in girls and women between the ages of 9 and 26; however, results from a manufacturer-sponsored randomized controlled trial of 3,811 patients showed it to be effective in preventing infection among women between 24 and 45 years old (Lancet 2009; 373: 1949–57).
EMA adopted positive opinions recommending marketing authorizations for several other medicines, including:
•Vernakalant (Brinavess, Merck), for the rapid conversion of atrial fibrillation to sinus rhythm in adults.
•Regadenoson (Rapiscan, Gilead), a pharmacological stress agent for radionuclide myocardial perfusion imaging.
•Conestat alfa (Ruconest, Pharming), an orphan medicine used to treat angioedema. Conestat alfa is a human protein produced using recombinant DNA technology and extracted from the milk of treated rabbits.
•Asenapine (Sycrest, Organon) for moderate to severe manic episodes associated with bipolar I disorder in adults.
•Velaglucerase alfa (Vpriv, Shire), an orphan medicine developed to treat Gaucher’s disease. EMA sped up the assessment of velaglucerase alfa to help provide an alternative to the authorized treatment, Cerezyme, whose manufacturer has been beset by production shortages.
Final marketing authorization on all of these is pending approval by the European Commission, which usually comes within a month of the EMA’s recommendations.
Finally, the EMA announced that it had begun a review of angiotensin II receptor inhibitors (the blood pressure-lowering drugs also known as angiotensin-receptor blockers) and possible cancer risks. The review follows the publication of a recent meta-analysis suggesting that that ARBs are associated with a modestly increased risk of new cancer diagnosis (Lancet Oncol. doi: 10.1016/S1470-2045(10)70106-6).
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日前，欧洲药品管理局(EMA)已建议批准多种新药的上市申请，并批准了其他几种产品扩大其适应证范围，包括降糖药依西奈肽(exenatide)和人乳头状瘤病毒(HPV)四价疫苗。
在每月一次的例会上，EMA人用医疗产品委员会决定批准扩大依西奈肽的适应证，允许其与噻唑烷二酮类药物联合用药。之前，依西奈肽(Byetta，礼来)已获得了在欧洲的上市许可，获准与二甲双胍和一种噻唑烷二酮类药物组成三药联合治疗方案用于2型糖尿病患者。EMA是于6月25日宣布这项决定的，今后依西奈肽可与噻唑烷二酮类药物组成两药联合治疗方案。
EMA还建议，将商品名为Gardasil (赛诺菲巴斯德)和Silgard (默克)的人乳头状瘤病毒四价疫苗的上市许可扩大至准许其用于年龄在45岁或45岁以下的女性。这种疫苗主要是用于生殖器病变、生殖器疣和宫颈癌的预防。这种疫苗最初获准用于年龄介于9~26岁的少女或妇女；但一项纳入了3,811例患者的由生产商资助的随机对照试验表明，对于年龄介于24~45岁的女性，这种疫苗亦可有效预防感染(Lancet 2009; 373: 1949–57)。
对于其他几种药物的上市许可，EMA也给出了肯定的推荐意见。其中包括：
• Vernakalant (Brinavess，默克)，用于成年患者将房颤快速转复为窦性心律。
• Regadenoson (Rapiscan，Gilead)，用于放射性核素心肌灌注显像的药理性压力剂。
• Conestat alfa (Ruconest，Pharming)，用于治疗血管性水肿的“孤儿药”(orphan medicine)。Conestat alfa是一种采用重组DNA技术生产的、从经过处理的家兔的乳汁中提取出来的人体蛋白。
• Asenapine (Sycrest，欧加农)，用于与双极性I型精神障碍相关的中重度躁狂发作的成年患者。
• Velaglucerase alfa (Vpriv，Shire)，用于治疗Gaucher病的“孤儿药”。EMA加快了对velaglucerase alfa的评审进度，以便尽量提供已获准药物Cerezyme的替代药物，Cerezyme的生产商一直以来都被产量短缺的问题所困扰。
上述所有药物的最终上市许可目前正在欧盟委员会的审批之中，通常会在EMA提供建议后的1个月内下达。
最后，EMA宣布其已经开始对血管紧张素II受体抑制剂 [降压药，又名血管紧张素受体阻滞剂(ARB)]与潜在癌症风险之间的关系进行评价。这件事情的起因是近期发表的一项Meta分析表明，ARB与新诊断癌症的风险略有增加相关(Lancet Oncol. doi: 10.1016/S1470-2045(10)70106-6)。
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