Research & development of Austedo (deutetrabenazine) : a case study
GAO Guang-hua
WANG Hai-xue
Abstract：Austedo was approved recently by FDA as a first deuterated new drug submitted in the class of 505 (b) (2),using the marketed tetrabenazine (TBZ) as the reference listed drug,for the treatment of chorea due to Huntington's disease (HD).Austedo experienced two cycles of NDA evaluation by FDA,and the major concern was the metabolite exposure difference between Austedo and TBZ,which was the critical factor for the bridging of the available data.The submitted nonclinical and clinical evidences were analyzed in this paper based on the FDA review reports,which may be helpful for the future evaluation of similar new drug submission.
Keywords：AustedoChorea due to Huntington's diseasedeutetrabenazinepharmacokineticsbridgeevaluation
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2159-2165 )