Among other things, the complete response letter includes certain assigned works for the company. FDA has said that the company need to conduct an additional clinical efficacy trial of Gencaro in patients with heart failure.
Moreover, the company has to conduct an additional clinical pharmacology studies to address drug-drug interaction and pharmacokinetic issues; and to conduct additional non-clinical studies to further characterize Gencaro metabolites.
FDA asserts that the best clinical study, which serves as the pivotal Phase III trial for the application, does not adequately demonstrate efficacy of Gencaro in reducing all-cause mortality in patients with heart failure.
In addition, the letter raises concerns as to the statistical significance of some of the pharmacogenetic data relied upon by the company to assert that individual patient response to Gencaro may be predicted by genotype.
ARCA believes that a comparative effectiveness analysis has demonstrated that Gencaro is as effective in reducing all-cause mortality as other ß-blocker therapies, when comparable patient populations are analyzed.
Michael Bristow, Founder and Chief Science and Medical Officer, ARCA, said: “The Company is reviewing the Complete Response letter and plans to discuss it with FDA as soon as possible”.
“We appreciate FDA’s review of the NDA and will continue to work with FDA to resolve the issues raised in the Complete Response letter,” he added.