Cardiome Pharma Corp. and its partner, Astellas Pharma US Inc., filed a new drug application seeking approval of RSD1235 for the acute conversion of atrial fibrillation. The filing comes about six months after Vancouver, British Columbia-based Cardiome reported positive data from a second Phase III trial. The NDA is based on a five-year clinical development program and includes data from two pivotal trials, ACT1 and ACT 3. Data from ACT 1 (Atrial Arrhythmia Conversion Trial 1) were released in December 2004, showing that the intravenous form of RSD1235 converted 52 percent of patients with recent onset atrial fibrillation to normal heart rhythm, while placebo converted only 4 percent. …
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