ARCA biopharma (ABIO) Receives Complete Response Letter From FDA Regarding NDA for GencaroTM - Cannot Approve in Current Form
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This morning, shares of ARCA biopharma (Nasdaq: ABIO) have fallen over 40% after receiving a Complete Response letter from the U.S. Food and Drug Administration (FDA, or the Agency) for its New Drug Application (NDA) seeking approval for GencaroTM (bucindolol hydrochloride) for the treatment of patients with chronic heart failure.
In its Complete Response letter, the FDA states that it cannot approve the NDA in its current form and specifies additional actions and information required by the Agency for approval of the Gencaro NDA. The Agency acknowledges that several substantial amendments to the NDA submitted by the Company in May 2009 were not reviewed or considered by the FDA in issuing the Complete Response letter, and that these amendments may be referenced in the Company’s response to the Complete Response letter. These unreviewed submissions deal with comparative effectiveness, clinical pharmacology, some aspects of pharmacogenetic data, and toxicology/metabolism.
Among other things, the Complete Response letter states that the Company must undertake the following actions to obtain approval:
Conduct an additional clinical efficacy trial of Gencaro in patients with heart failure; Conduct additional clinical pharmacology studies to address drug-drug interaction and pharmacokinetic issues; and,
Conduct additional non-clinical studies to further characterize Gencaro metabolites.
In its Complete Response letter, 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.
ARCA biopharma, Inc. (ARCA), formerly Nuvelo, Inc. is a biopharmaceutical company focused on developing genetically-targeted therapies for heart failure and other cardiovascular diseases. [SM]
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