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首页> 外文期刊>Prescrire international >Assessment of mepolizumab in children: an overpermissive agency!
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Assessment of mepolizumab in children: an overpermissive agency!

机译：评估儿童莫贝尔替米布：一种矫直机构！

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The assessment of mepolizumab in children with severe asthma is a new example of an inadequate evaluation in paediatrics, which should have led to refusal of marketing authorisation (MA) (see "Mepolizumab and severe asthma in patients aged 6 years and older" p. 11) (1). In children with severe asthma inadequately controlled by inhaled corticosteroids, one would expect in-depth evaluation of a new drug, in order to address the questions raised, in the interest of these young patients. Is the drug more effective than an oral corticosteroid? Does it cause fewer adverse effects? What are its long-term adverse effects, in particular on children's growth? The assessment of mepolizumab in children, carried out in a few dozen children for a few months at most, was really not designed to provide answers to these questions. The company justified its actions by arguing that persistent severe "eosinophilic" asthma (a diagnostic entity with no consensus definition as of 2019) is rare in children and that to carry out high-quality trials in this context would have taken time, thus delaying access to mepolizumab for children. The company also points out that the data from adults can be extrapolated to children (2). These arguments mainly serve as an excuse for fulfilling regulatory obligations concerning drug evaluation in children at a lower cost.
机译：评估患有严重哮喘的儿童的牛醇蛋白是对儿科评估不充分的新例子，这应该导致销售授权（MA）（参见6岁及以上患者的植物司布和严重的哮喘“11 ）（1）。在受吸入皮质类固醇的严重哮喘患儿的儿童中，人们会期望对新药进行深入评估，以解决这些年轻患者的提出的问题。药物是否比口腔皮质类固醇更有效？它是否会导致更少的不利影响？它是什么长期不利影响，特别是儿童的增长？最多几个月在几十个孩子中进行了对儿童进行的植物中的评估实际上并非旨在为这些问题提供答案。本公司通过争论持续严重的“嗜酸性友好”哮喘（截至2019年没有共识定义的诊断实体辩论，在儿童中罕见，在这种情况下进行高质量试验，通过争辩地辩护其行为是罕见的，因此在这种情况下进行高质量的试验将需要花时间，从而延迟访问对儿童的莫博提姆。该公司还指出，成人数据可以推断给儿童（2）。这些论点主要是履行以较低的成本履行儿童药物评估的监管义务的借口。

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    《Prescrire international》 |2020年第211期|共1页
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  • 中图分类 药学;
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