Cardiome Pharma Corp. said the US Food and Drug Administration (FDA) has delayed its decision on a New Drug Application (NDA) for a heart treatment drug Kynapid (vernakalant hydrochloride).
Cardiome and its co-development partner Astellas Pharma US, Inc. said that the federal authorities did not provide an action letter prior to the PDUFA date of January 19, 2008.
"While we look forward to the FDA reaching a decision, we respect their need for additional time to review the Kynapid NDA," said William E. Fitzsimmons, PharmD, senior vice president, research & development, Astellas. "Astellas and Cardiome strongly believe in the therapeutic value of Kynapid based on clinical trial data and are confident it will be an important therapy in the treatment of atrial fibrillation."
In October 2003, Cardiome granted Astellas an exclusive license to develop and commercialise Kynapid in North America. Cardiome has retained all rights to the intravenous formulations outside of Canada, the US and Mexico. The NDA for Kynapid, based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 6-2 in favour of recommending to the FDA that Kynapid be approved for the rapid conversion of acute AF to sinus rhythm.
Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation. Positive top-line results from two pivotal Phase 3 trials for vernakalant (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome's co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006. Positive top-line results from an additional phase III study evaluating patients with post-operative atrial arrhythmia, called ACT 2, were released in June 2007. An open-label safety study evaluating recent-onset AF patients, called ACT 4, has completed.
Vernakalant (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a phase IIa pilot study for vernakalant (oral) in September 2006. A phase IIb study for vernakalant (oral) is ongoing.
In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC for all indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalised following a heart attack.