Astellas/Cardiome's drug gets longer FDA review

Canadian drug developer Cardiome Pharma and Astellas Pharma US, a subsidiary of Japan's Astellas, say that the Food and Drug Administration has requested additional data on the developmental arrhythmia treatment vernakalant HCl. Cardiome licensed the drug to Astellas in 2003 (Marketletters passim).

The vernakalant HCl New Drug Application was first accepted for review by the FDA earlier this year, having been initially rejected due to what the agency described as "inconsistencies and omission" (Marketletter January 1 & 8). The firms have been asked to provide the additional information in time for a review by the FDA's Cardiovascular and Renal Drugs Advisory Committee, scheduled for December 11.

The companies responded by saying that they welcomed the opportunity to present additional data to the FDA, adding that they would include safety and efficacy data from the ACT-2 trial that was not available previously. Astellas president Yoshihiko Hatanaka said that "data from the ACT 2 trial offers both the FDA and the advisory committee additional insight regarding vernakalant as a potential new treatment option." The FDA is expected to reach a final approval decision in January next year.