BrinavessTreatment for Atrial Fibrillation
Cardiome And Astellas Announce Acceptance Of NDA For Review
VANCOUVER and DEERFIELD, IL, February 19, 2007 -- Cardiome Pharma Corp. and its co-development partner Astellas Pharma US, Inc. today announced that the New Drug Application (NDA) for the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation, has been accepted for review by the U.S. Food & Drug Administration (FDA).
The NDA for vernakalant (iv) was submitted in December 2006, and is based on a 5-year clinical development program. Upon approval, vernakalant (iv) will be marketed in the United States by Astellas Pharma US, Inc., a US affiliate of Astellas Pharma Inc. The trade name for the marketed product has not yet been determined.
In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize vernakalant (iv) in North America. The companies have co-developed vernakalant (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.
Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). 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. An additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, and an open-label safety study evaluating recent-onset AF patients, called ACT 4, are ongoing. Cardiome's co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006.
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 2a pilot study for vernakalant (oral) in September 2006.
Posted: February 2007
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