Full Article Reprinted from "The Pink Sheet" DAILY- September 23, 2008
Read about why the 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.
Full Article Reprinted from "The Pink Sheet" DAILY - September 23, 2008
ARCA Files NDA For Bucindolol; First Genetically Targeted CV Therapy?
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.
"While currently available beta blockers are a mainstay in medicine, it is difficult for physicians to predict which patients will respond to which therapy," Michael Bristow, ARCA chairman, said in a release. "Bucindolol interacts with certain polymorphism of adrenergic receptors that help regulate cardiac function, allowing us to predict patient clinical response using a simple genetic test."
In 2007, privately held ARCA inked a collaboration agreement with Laboratory Corporation of America, which is preparing a Premarket Approval application for the genomic test to submit to FDA's Center for Devices and Radiological Health (1"The Gray Sheet," Feb. 19, 2007, In Brief).
Bucindolol is a beta blocker that was in Phase III development by Bristol-Myers Squibb. Bristol shelved the drug after other beta blockers -- GlaxoSmithKline's Coreg (carvedilol) and AstraZeneca's Toprol (metoprolol) beat it to FDA approval (2"The Pink Sheet" DAILY, June 5, 2008).
However, Denver-based ARCA's founder, cardiologist Michael Bristow, regained rights to the drug candidate and through further research found that it showed greater efficacy in patients with polymorphisms in two adrenergic receptors that help regulate cardiac function: beta1 389 Arg/Gly and alpha2c 322-325 WT/Del.
The firm identified three distinct genotypes that predict bucindolol's effect, labeling them "very favorable," "favorable" and "unfavorable." Those in the very favorable category make up about half the population with heart failure.
Phase III data supporting the NDA were reported Sept. 22 at the Heart Failure Society of America meeting in Toronto. The prospectively designed DNA sub-study included more than 1,000 U.S. patients enrolled in the Beta Blocker Evaluation of Survival Trial (BEST).
Bucindolol significantly reduced hospitalization and death among heart failure patients with the "very favorable" genotypes, which accounted for 47 percent of BEST patients. Those in this category had statistically significant reductions in all cause mortality (38 percent), cardiovascular mortality (48 percent), heart failure hospitalization (44 percent), cardiovascular hospitalization (36 percent), and all cause mortality or transplant (43 percent).
In a recent interview with "The Pink Sheet" DAILY, ARCA CEO Richard Brewer said the firm expects to launch the drug by itself in the second half of 2009, targeting cardiologists. It also plans to conduct Phase III studies in atrial fibrillation next year (3"The Pink Sheet" DAILY, June 6, 2008).
- Pamela Taulbee
Companys mentioned in this article
GlaxoSmithKline
ARCA
Click here to start your 30-day, risk-free trial of "The Pink Sheet" DAILY – Immediate business intelligence from the company and product level up.
