Solvay announced today that its dossier for intravenous tedisamil (intended brand name: PULZIUM® IV), a new chemical entity coming from Solvay Pharmaceuticals R&D laboratories, has been filed for approval by the US Food and Drug Administration (FDA) as well as by the authorities of European Union countries. This means that the formal processing and review have begun.
The regulatory submission is based on safety and efficacy studies that evaluated PULZIUM® IV for the rapid conversion of recent onset atrial fibrillation or atrial flutter to normal sinus rhythm in more than 1000 patients with symptomatic atrial fibrillation or flutter. PULZIUM® IV is a class III anti-arrhythmic drug which blocks multiple potassium channels.
“We believe that PULZIUM® IV represents a valuable treatment option for cardiologists treating patients with recent onset atrial fibrillation or flutter. Used as a 30 minute intravenous infusion, it converts atrial flutter or fibrillation back to sinus rhythm and becomes a worthwhile addition to the other cardiometabolic treatments we offer”, said Claus Steinborn, Executive Vice President R&D 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 cardio-metabolic, neuroscience, influenza vaccines, gastroenterology, specialized markets and men’s and women’s health. Its 2006 sales were EUR 2.6 billion and it employs approximately 10,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 29,000 people in 50 countries. In 2006, its consolidated sales amounted to EUR 9.4 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay (Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the Euronext stock exchange in Brussels. Details are available at www.solvay.com
