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ARCA Biopharma (ABIO) has received a complete response letter from the FDA for Gencaro (bucindolol).

The FDA says that it cannot approve the NDA in its current form and specifies the need for additional actions and information.

The letter says that the BEST clinical study (the pivotal Phase 3 trial for the application), does not adequately demonstrate efficacy of Gencaro in reducing all-cause mortality in patients with heart failure. The letter raises concerns regarding the integrity of the BEST data based on its audit of certain clinical sites involved in the BEST trial, which may require an independent audit of additional clinical sites and other actions to verify the integrity of the data. In addition, the letter raises concerns as to the statistical significance of some of the pharmacogenetic data relied upon by ABIO to assert that individual patient response to Gencaro may be predicted by genotype.

Here’s what they need for approval:

• Additional clinical efficacy trial of Gencaro in patients with heart failure;

• Additional clinical pharmacology studies to address drug-drug interaction and pharmacokinetic issues;

• Additional non-clinical studies to further characterize Gencaro metabolites.

ABIO CMO/CSO Michael Bristow said this:

“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.”

We wrote about ABIO a few weeks ago as they laid off 40 employees ahead of their PDUFA data, and we profiled the company back in January.

Stay tuned…

Anonymous Tip? Comments? Contact us at: hr@iguanabio.com

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