A Survey of Evidence of Restricted Indications Approved for New Drugs

新藥核准限制性適應症之實證依據

林勇良(Yeong-Liang Lin) ； 林敏雄(Min-Shung Lin) ； 陳建煒(K. Arnold Chan)

《臺灣家庭醫學研究》 4卷2期 (2006/04) Pp. 70-77

https://doi.org/10.29475/TFMR.200604.0002

摘要

為了解新藥核准之限制性適應症，以便日復核准新藥之適應症時，得以在特定之需要情況下，限制某種程度病患方得使用，例如輕微、中度或重度乾癬，本研究回顧自1996年7月至2002年7月經美國食品及藥物管理局核准之新藥仿單，將其中具限制性適應症之案例挑出，在這些案例中，仿單及新藥評估報告中臨床試驗之納入條件是否要求受試者必須具備某程度之疾病之資訊，作者逐一整理並分析其類別與疾病，經研究，總共收集到20例被核准限制性適應症之新藥，除一案例因資料不足外，其他案例於臨床試驗中皆要求受試者必須具備某一程度之疾病，且此一疾病嚴重程度與核准之適應症疾病嚴重程度相同。

並列摘要

We reviewed the indications of new drugs approved by the Center for Drug Evaluation and Research, Food and Drug Administration (FDA) between July 1996 and July 2002 and we identified those approved for restricted indications in order to assess the reasons for restricted indications of prescription drugs, which are indications with the specific terms of mild, moderate, severe, mild to moderate, moderate to severe, or moderately severe for disease severity. We analyzed the FDA review reports and labels for these drugs to determine whether the inclusion criteria in their pivotal studies required certain levels of disease severity to be eligible for participation and whether the disease severity was the same as those subsequently approved in the indications. We found that a total of 20 drugs were approved for restricted indications. With the exception for one drug for which there was insufficient public information, all of these drugs required certain levels of disease severity in their pivotal studies and the severity levels were the same as those approved in their indications.