PMDAジョイントシンポジウム：産官学で拓く神経疾患の治療推進
日本発の神経疾患治療薬開発の実例：Lewy小体型認知症治療薬
2016 年 33 巻 2 号 p. 263-267
詳細
2016 年 33 巻 2 号 p. 263-267
In 2014, donepezil was approved for treatment of dementia with Lewy bodies (DLB) in Japan, and became the world's first licensed medicine for DLB. Because of severe cholinergic dysfunction in DLB, cholinesterase inhibitors (ChEIs) have been thought to be highly effective, and several clinical trials have demonstrated favorable potential of ChEls such as rivastigmine and donepezil for DLB. Most of the trials, however, were open–labeled, and no ChEI had been approved for DLB.
Thus, clinical development of donepezil for DLB was initiated in 2007. As there was no precedent, many challenges were faced during the development. In this article, the history of development was described in light of the challenges.
