Brinavess
Generic name: vernakalant
Treatment for: Atrial Fibrillation
Cardiome Announces Refusal to File Decision By the FDA
VANCOUVER, May 31, 2006 -- Cardiome Pharma Corp. today announced that its co-development partner, Astellas Pharma US, Inc., has received a "refusal to file" letter from the U.S. Food & Drug Administration for the New Drug Application (NDA) for RSD1235 (iv), an investigational new drug for the acute conversion of atrial fibrillation.
In accordance with application regulations, the FDA is required to accept or refuse an application within 60 days of the completion of the filing, which occurred on March 31, 2006. Neither the acceptance nor non-acceptance of the NDA filing is a determination of the approvability of RSD1235 (iv).
"We are very disappointed to communicate this setback to our stakeholders," said Doug Janzen, President and Chief Business Officer of Cardiome. "Based on the clinical data generated from this program, we had great confidence that the submission would have met the Agency's filing requirements. Following this FDA decision, we will engage in discussions with our partner seeking greater involvement in the regulatory pathway."
In its communication, the FDA cited inconsistencies and omissions in the database submitted with the NDA application. Cardiome intends, with its partner Astellas, to meet with the FDA as soon as possible to discuss the issues raised, and to determine what remedies are required for the filing to be accepted. Following this discussion with the FDA, Astellas and Cardiome will be better able to assess the timing for addressing the FDA's issues in order to move the application process forward.
"Our confidence in this program is in no way affected by this event," said Bob Rieder, Chief Executive Officer of Cardiome. "We are reviewing our own efforts in relation to this NDA, and are fully committed to resolving the FDA's concerns as quickly as possible."
Pursuant to the license agreement between Cardiome and Astellas, a US$10 million milestone payable to Cardiome is triggered on acceptance of the NDA for review. This milestone remains outstanding pending acceptance of the NDA.
About RSD1235
RSD1235 (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 RSD1235 (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. A New Drug Application (NDA) for RSD1235 (iv) was submitted to the U.S. Food and Drug Administration in March 2006 by Cardiome's co-development partner, Astellas Pharma US, Inc. 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.
RSD1235 (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. A Phase 2a pilot study for RSD1235 (oral) was initiated in December 2005.
Posted: May 2006
Related articles
- Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events - December 24, 2019
- Correvio Announces Outcome Of FDA Advisory Committee Meeting Reviewing Brinavess For The Treatment Of Recent Onset Atrial Fibrillation - December 10, 2019
- FDA Accepts Correvio's Resubmitted New Drug Application for Brinavess (vernakalant) - July 25, 2019
- Correvio Resubmits Brinavess (vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation - June 24, 2019
- Cardiome Provides U.S. Regulatory Update for Brinavess - August 21, 2017
- Additional Clinical Trial to be Conducted for Kynapid Under FDA Special Protocol Agreement - August 12, 2009
- Cardiome Provides Kynapid Regulatory Update - October 9, 2008
- Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For Kynapid - August 11, 2008
- Cardiome And Astellas Announce Kynapid Regulatory Update - January 22, 2008
- FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation - December 12, 2007
- Cardiome And Astellas Announce Regulatory Extension - August 30, 2007
- Cardiome And Astellas Announce Acceptance Of NDA For Review - February 19, 2007
- Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV) - December 18, 2006
- New Drug Application Submitted For RSD1235 - March 31, 2006
Brinavess (vernakalant) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
