Monday, August 5, 2013
FDA's Norman Stockbridge wants to abandon thorough QT
studies by 2015, replacing them with a preclinical assay suite better able to
detect proarrhythmia side effects than existing assays. However, it remains
unclear whether two years is sufficient time to develop and validate the assays
to a level that convinces stakeholders the QT trials are no longer necessary.
According to Stockbridge,
director of CDER's Division of Cardiovascular and Renal Products, the new
approach is needed because the focus on QT prolongation under the agency's
current guidance has likely hindered drug development, potentially killing
compounds that do not in fact cause fatal arrhythmia.