Brinavess
Generic name: vernakalant
Treatment for: Atrial Fibrillation
New Drug Application Submitted For RSD1235
VANCOUVER and DEERFIELD, IL, March 31, 2006 -- Cardiome Pharma Corp. and its co-development partner Astellas Pharma US, Inc. today announced Astellas' submission of a New Drug Application (NDA) to the United States Food & Drug Administration (FDA) seeking approval to market the intravenous formulation of RSD1235, an investigational new drug for the acute conversion of atrial fibrillation.
The NDA is based on a 5-year clinical development program for RSD1235 (iv), which, upon approval, will be marketed in the United States by Astellas Pharma US, Inc., a US subsidiary of Astellas Pharma Inc. The trade name for the marketed product has not yet been determined.
"The submission of this NDA represents the culmination of years of clinical development effort, and is certainly the most exciting milestone we have yet achieved as a company," stated Bob Rieder, Chief Executive Officer of Cardiome. "I would like to thank all of the Cardiome and Astellas employees who have worked so hard to ensure that this NDA was submitted as planned."
"With the timely submission of this NDA, we have taken another important step in the development process of RSD1235," stated William E. Fitzsimmons, Pharm.D., Senior Vice President, Business Development of Astellas. "The collaborative efforts that Cardiome and Astellas put forth to achieve this goal are the result of a successful partnership with a mutual commitment to success."
In October 2003, Cardiome granted Astellas an exclusive license to develop and commercialize the intravenous 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, U.S. and Mexico, and has also retained worldwide rights to oral RSD1235 for the prevention of atrial fibrillation.
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. Immediate symptoms are breathlessness and fatigue. Long-term effects include increased risk of both stroke and congestive heart failure.
Posted: March 2006
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Brinavess (vernakalant) FDA Approval History
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