FDA Recommends Approval Of KYNAPID For Acute Atrial Fibrillation
Cardiome Pharma, Astellas Pharma announced that FDA recommended approval of KYNAPID, the intravenous formulation of vernakalant hydrochloride, an investigational new drug for rapid conversion of acute atrial fibrillation.
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 decisions are made by the FDA. An action further to the FDA review of KYNAPID is expected on or before January 19, 2008.
KYNAPID is the proposed brand name in North America for the intravenous formulation vernakalant hydrochloride, and has been provisionally accepted by the FDA. Final approval of provisionally accepted names is granted upon approval of the investigational drug. The NDA for KYNAPID, based on a five-year clinical development program, was submitted in December 2006 and accepted for review by the FDA in February 2007.
In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize KYNAPID in North America. Cardiome has retained all rights to the intravenous formulations outside of Canada, the U.S. and Mexico. Upon approval, KYNAPID will be marketed in the United States by Astellas Pharma US, Inc., a U.S. affiliate of Astellas Pharma Inc.