September 15th, 2010
FDA: Ticagrelor Deadline Extended; No Clear Signal on Sibutramine
FDA watchers require patience.
AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the FDA were uncertain about how best to interpret the results of the pivotal PLATO trial because the overall positive effects of the drug were not observed in the subset of patients enrolled in the U.S. (AstraZeneca press release.)
The FDA Endocrinologic and Metabolic Drugs Advisory Committee split down the middle in its review of sibutramine (Meridia). Eight panel members voted in favor of withdrawing sibutramine from the U.S. market, while 8 members voted to keep it on the market, though all 8 agreed it needed a boxed warning and 6 thought it also should have its distribution limited to specially trained physicians. No panel members thought it should be allowed to remain on the market without any changes to the current label.