ARTICLE | Clinical News

Gencaro bucindolol regulatory update

December 7, 2009 8:00 AM UTC

FDA granted Fast Track designation to Arca for Gencaro bucindolol to reduce cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. The company said the genotype most favorable for treatment with the non-selective beta blocker is homozygous arginine at the amino acid position 389 beta-1 adrenergic receptor polymorphism. This quarter, the company plans to submit an SPA for a Phase III trial comparing Gencaro to metoprolol in the population, and hopes to start the trial late next year or in 1H11. Arca said a successful trial could lead to inclusion of the specific genotype in the indication section of Gencaro's labeling, but that other genotypes would not be specifically excluded. ...