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news.Astellas Pharma US has submitted a new drug application to the FDA seeking approval to market an intravenous formulation of RSD1235, an investigational drug for the acute conversion of atrial fibrillation being co-developed with Cardiome Pharma.
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Atrial fibrillation, the most common cardiac arrhythmia, is an abnormal heart rhythm that affects the upper chambers of the heart, lowering the heart’s pumping capacity. The new drug application (NDA) is based on a five-year clinical development program for intravenous RSD1235.
“With the timely submission of this NDA, we have taken another important step in the development process of RSD1235,” stated Dr William Fitzsimmons, senior vice president of business development at Astellas.
In October 2003, Cardiome granted Astellas an exclusive license to develop and commercialize the intravenous (IV) formulation of RSD1235 in North America. The companies have co-developed RSD1235 (IV) to NDA, with Astellas responsible for 75% of development costs.
Cardiome has retained all rights to the intravenous formulations outside of Canada, US and Mexico, and has also retained worldwide rights to oral RSD1235 for the prevention of atrial fibrillation.