KynapidTreatment 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.
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.
Source: Cardiome Pharma Corp.
Posted: May 2006
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