FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA... (ndolol we are taking a majorstep forward...)

FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma

Date:9/23/2008

ndolol, we are taking a major step forward in our quest to bring the benefits of personalized medicine to cardiovascular disease," said Richard B. Brewer, president and chief executive officer of ARCA biopharma. "We look forward to working with the FDA to make bucindolol available to physicians and patients. We are also working with our partner, LabCorp of America, to develop and introduce a companion genetic test."

In the genetic sub-study of the BEST trial, researchers categorized patients into three groups based on receptor genotype: very favorable, favorable and unfavorable. Patients with the very favorable genotype experienced significant improvements in clinical endpoints compared to placebo, including reductions in all cause mortality, all cause mortality or transplant, cardiovascular mortality, heart failure hospitalization, and cardiovascular hospitalization. While the most robust clinical effects occurred in the very favorable genotype group, patients with the favorable genotype also benefited from treatment with bucindolol. Bucindolol also demonstrated clinically significant improvements in ischemic endpoints including reducing the risk of myocardial infarction. Patients with the unfavorable genotype, approximately 10 percent of the study population, did not respond to bucindolol therapy.

About Beta Blockers

The use of beta blockers is the standard of care in patients with heart failure and left ventricular dysfunction, according to clinical practice guidelines of the Heart Failure Society of America (HFSA), the American Heart Association, and the American College of Cardiology. HFSA guidelines state: "Beta-blocker therapy remains a major advance in the treatment of patients with LV systolic dysfunction. Along with ACE inhibitors, this class of drug is now established as routine therapy in patients with LV systolic dysfunction."

About Heart Failure

Heart failure is a chronic and progressive condition in which the heart c
'/>"/>

0

GOOD

Page: 1 2 3
Related biology technology :

1. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
2. FDA Accepts Sucampos sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
3. FDA Accepts Ranexa(R) sNDA and NDA for Filing
4. EMEA Accepts for Review Vidaza(R) Marketing Authorization Application for Higher-Risk Myelodysplastic Syndromes
5. Imaging Diagnostic Systems Accepts Resignations of Outside Directors
6. U.S. Government Accepts $192 Million of sanofi pasteur H5N1 Bulk Vaccine Antigen for Pandemic Stockpile
7. FDA Accepts Zingo(TM) Supplemental New Drug Application to Reduce Pain Associated With Peripheral Needle Insertion Procedures in Adults
8. FDA Accepts Immucors Response to Warning Letter
9. Hologic, Inc. Accepts Shares of Third Wave Technologies, Inc. in Tender Offer and Commences Subsequent Offering Period
10. GSI Group Accepts Shares in Tender Offer for Excel Technology and Commences Subsequent Offering Period
11. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera

Post Your Comments:

FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA...(ndolol we are taking a majorstep forward...)