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news.Cardiome and Astellas Pharma have reported the re-submission of the new drug application to the FDA for vernakalant hydrochloride, after the FDA refused to file the initial application for the drug.
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Vernakalant hydrochloride is an investigational new drug for the acute conversion of atrial fibrillation. The two companies have submitted more information after the initial application was rejected.
“This re-submission is the culmination of a comprehensive and thorough review process conducted by Astellas Pharma US, Cardiome and outside consultants,” stated Dr Charles Fisher, executive vice president 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 new drug application Astellas has submitted for the FDA’s consideration.”
Pursuant to the amended co-development agreement made in July 2006, between Cardiome and Astellas Pharma US, a $10 million milestone payable to Cardiome has been triggered on re-submission of the new drug application.