Brinavess
Generic name: vernakalant
Treatment for: Atrial Fibrillation
Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV)
VANCOUVER and DEERFIELD, IL December 18, 2006 -- Cardiome Pharma Corp. and its co-development partner, Astellas Pharma US, Inc., today announced Astellas' re-submission of the New Drug Application (NDA) to the United States Food & Drug Administration (FDA) seeking approval to market the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation.
"This re-submission is the culmination of a comprehensive and thorough review process conducted by Astellas Pharma US, Inc., Cardiome and outside consultants," stated Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "With the inclusion of an additional 150 patients in the safety dataset from the ongoing ACT 2 and ACT 4 studies, we are pleased with the NDA Astellas has submitted for the FDA's consideration."
"With this NDA, we have taken an important step forward in the development process of this therapeutic candidate," stated William E. Fitzsimmons, Pharm.D., Senior Vice President, Business Development at Astellas Pharma US, Inc. "The collaborative effort between Cardiome and Astellas Pharma US, Inc. has been emblematic of our successful development partnership and mutual commitment to success."
Pursuant to the amended (July 2006) co-development agreement between Cardiome and Astellas Pharma US, Inc., a US$10 million milestone payable to Cardiome has been triggered on re-submission of the NDA.
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: December 2006
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Brinavess (vernakalant) FDA Approval History
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