NASDAQ: CRME TSX: COM
VANCOUVER and DEERFIELD, IL, Dec. 11 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended that the FDA approve KYNAPID(TM), the intravenous formulation of vernakalant hydrochloride, an investigational new drug for rapid conversion of acute atrial fibrillation (AF).
At the panel review conducted today in Maryland, the members voted 6 to 2 in favour of recommending to the FDA that KYNAPID be approved for the rapid conversion of acute AF to sinus rhythm. If approved, KYNAPID will be the first new pharmacologic therapy for the conversion of AF in eight years.
"We are pleased with the committee's recommendation," said William E. Fitzsimmons, PharmD, Senior Vice President, Research & Development at Astellas. "We strongly believe in the therapeutic value of KYNAPID based on clinical trial data and are confident it will be an important therapy for people with atrial fibrillation."
"We welcome the committee's recommendation for approval, and look forward to the FDA completing their review and acting on the application early in the new year," stated Bob Rieder, Chief Executive Officer and Chairman of Cardiome. "People with atrial fibrillation suffer significant disease burden, and we are pleased to move an important step closer to providing doctors with an important tool for meeting this critical unmet medical need."
The Cardiovascular and Renal Drugs Advisory Committee is convened on
request of the FDA, and reviews and evaluates available data concerning the
safety and effectiveness of human drug products for use in the treatment of
cardiovascular and renal disorders. Although the Committee provides
recommendations to the Agency and suggests a course of action, final
|SOURCE Cardiome Pharma Corp.|
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