Cardiome believes FDA's refusal of RSD1235 linked to presentation, not data

By Jennifer Lanning Drey

Eugene, Ore., May 31 - Cardiome Pharma Corp. believes the Food and Drug Administration's "refusal to file" letter regarding the New Drug Application for RSD1235 (iv) reflects errors in the execution of the application, not the underlying data, according to Bob Rieder, chief executive officer for Cardiome.

"To the best of our knowledge, their comments do not relate to the ultimate sufficiency of this clinical data set but to deficiencies in the way that the data was presented in the filing," said Rieder during a company conference call held Wednesday.

Cardiome's co-development partner, Astellas Pharma US, Inc., received the refusal to file letter on Tuesday. In the letter, the FDA cited inconsistencies between the submission document and the underlying locked data set and omissions of data supporting the submission document, Rieder said during the call.

The letter did not allude to there being a question about the clinical data, he said.

"Indeed there is no way in the short time that the agency had the document that they would have had time to review the data base and form a judgment about whether the data set itself supports our assertions in the NDA," Rieder said.

RSD1235 (iv) is an investigational new drug for the acute conversion of atrial fibrillation.

The FDA found the errors in the NDA during a routine audit of patient data, and Cardiome believes they may be the result of the electronic filing format used to submit the application, Rieder said during Wednesday's call.

Cardiome expects to meet with the FDA in the next 30 days to discuss the problems with its application, and the company expects to be able to re-submit the NDA for RSD1235 (iv) in the third quarter.

"Our primary objective going forward from here is not timing but the quality of the ultimate resubmission," Rieder said.

Cardiome and Astellas plan to hold a senior level meeting within the next week to discuss the resubmission of the application.

"We respect the agency's views very much and are chagrinned to be associated with this kind of event, but we believe that we, and our partner Astellas, can respond to these concerns," said Rieder, during the call.

Cardiome is a cardiovascular drug-development company based in Vancouver, B.C.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.