ARCA Filing For Bucindolol Could Bring First Genetically Targeted CV Therapy
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA has accepted an NDA for Gencaro (bucindolol), which could be the first cardiovascular drug approved with an accompanying pharmacogenomic test, ARCA Biopharma said Sept. 23
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Laboratory Corporation of America and ARCA Discovery, a private biopharmaceutical company, will collaborate to develop a commercial genetic test to aid in prescribing bucindolol, a heart failure drug in development by ARCA. Bucindolol's efficacy appears to vary with the genetic makeup of patients: Certain variants are associated with a strong positive benefit while others have side effects and no benefit, according to the companies. The biopharma firm has extensive Phase III efficacy and safety data in heart failure patients, and plans to apply for FDA approval in 2007, the companies announced Feb. 13. A study published in a recent Proceedings of the National Academy of Sciences showed that a common genetic variation in the beta-1 adrenergic receptor may help doctors identify heart failure patients who would benefit most from bucindolol. Another genetic variant, of the alpha-2c-adrenergic receptor, could have similar benefit, according to data presented at the 2005 American Heart Association meeting...