FDA Refuses To File Cardiome/Astellas RSD1235 NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Cardiome says a third quarter resubmission of its anti-arrhythmic product will not require additional clinical data.
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FDA's refusal to file Cardiome/Astellas' NDA for RSD1235 could set the anti-arrhythmic back by up to six months, Cardiome CEO Bob Rieder said May 31. Cardiome expects to resubmit the NDA for RSD1235 for acute conversion of atrial fibrillation in the third quarter; the companies originally filed March 31. The firm's co-development partner Astellas received a refusal to file letter from the agency May 30 citing "inconsistencies and omissions in the database submitted with the NDA application," according to Cardiome. "There wasn't a request for additional clinical data in the FDA's letter," Cardiome President Doug Janzen said in a conference call May 31. "Their request was quite clear about...accurate and consistent data and that's what we'll be endeavoring to do here in the short-term." "We don't think there's any chance [that we did not collect the data FDA is looking for]," Rieder said. Although the letter points to the Astellas-conducted Phase III ACT 3 trial, Cardiome feels that "trying to assign blame for this is much too early, and I'm not sure it's a constructive exercise. Both we and Astellas are very committed to getting this right and getting it back on track," Rieder said. "It appears, at this point in time, as if at least some part of the omissions and inconsistencies that are referred to in this letter might - might, I emphasize - relate to the electronic format of the filing," Rieder noted. The RSD1235 NDA was filed as an electronic common technical document; such filings have caused delays for several products, including Eisai's epilepsy drug rufinimide (1 (Also see "Eisai Rufinamide Electronic Resubmission Aims To Make NDA More Accessible" - Pink Sheet, 18 Nov, 2005.)). FDA issued a final guidance on electronic submissions in October; electronic submissions of product labeling was made mandatory a month later. Cardiome said the companies hope to meet with FDA in the next 30 days. "This is a bit of an embarrassment to Cardiome and we will be endeavoring to make sure that the agency receives a package that they are comfortable with, whether that takes a week or a few months....We don't expect that it will take more than a quarter, but...quality is going be more paramount in our minds than absolute speed on getting the resubmission in," Janzen said. Rieder has previously lauded the clinical performance of RSD1235 compared with amiodarone, suggesting that Cardiome's product could be priced at a premium (2 (Also see "Cardiome Expects Anti-Arrhythmic NDA Submission By 2006" - Pink Sheet, 21 Dec, 2004.)). According to the firms' licensing agreement, Cardiome will receive a $10 mil. milestone payment from Astellas on acceptance of the NDA for review. -Mary Bruce |