PulziumTreatment for Atrial Flutter, Atrial Fibrillation
Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
MARIETTA, Ga., December 12, 2007 /PRNewswire/ -- Solvay Pharmaceuticals, Inc., announced today that the company will continue to work closely with the U.S. Food and Drug Administration (FDA) to fully address the questions raised by members of the Cardio-Renal Advisory Committee in its meeting to consider tedisamil as a treatment for rapid conversion of recent onset atrial fibrillation to normal sinus rhythm (NSR).
The Committee voted against approval of tedisamil, at this time, requesting that Solvay Pharmaceuticals provides additional information to the Agency. While not binding, the Committee's recommendations will be considered by the FDA in its review of the New Drug Application (NDA) for tedisamil.
"Although we are disappointed with today's vote, we remain committed to working with the FDA to determine appropriate next steps in the review of this drug application," said Laurence Downey, M.D., President and CEO of Solvay Pharmaceuticals, Inc.
The New Drug Application (NDA) for tedisamil was filed with the FDA in December 2006. Following Solvay Pharmaceuticals' submission of additional clinical data amending the NDA for tedisamil, FDA extended the typical 10- month review period. Under this revised timeline, Solvay Pharmaceuticals anticipates action from the FDA on or before January 19, 2008.
About Atrial Fibrillation
Atrial fibrillation (AFib) is an abnormal heart rhythm, known as a cardiac arrhythmia, affecting the upper chambers of the heart (atria). In this condition, the electrical signals in the atria that are responsible for directing the activity of the lower chambers of the heart (ventricles) become unsynchronized, and the ventricles continue pumping, usually irregularly and rapidly. This fast, uncoordinated rhythm prevents the heart from efficiently pumping blood out to the body. Some heart conditions associated with AFib include hypertension, heart failure, and coronary artery disease.
AFib -- the most common clinically relevant arrhythmia with an overall prevalence that increases with age -- affects more than 2 million adults in the U.S. This common sustained cardiac rhythm disorder is associated with substantial mortality and morbidity from stroke, thromboembolism and heart failure.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals.
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology, and men's and women's health. Its 2006 sales were EUR 2.6 billion and it employs approximately 10,000 people worldwide.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30,000 people in 50 countries. In 2006 its consolidated sales amounted to EUR 9.4 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY is listed on the Euronext stock exchange in Brussels.
Posted: December 2007
- Solvay Pharmaceuticals, Inc. Announces FDA Extension of Tedisamil PDUFA Date - September 26, 2007
- Solvay Pharmaceuticals Files Tedisamil, a New Cardiometabolic Product for the Treatment of Atrial Fibrillation and Atrial Flutter - April 25, 2007