If the FDA follows the panel's recommendations, as it usually does, the drug will be the first within-class competitor for clopidogrel (Plavix).
The Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approving prasugrel for use in unstable angina non-ST-segment heart attack patients and in ST-segment heart attack patients.
One committee member who had publicly expressed deep reservations about prasugrel's safety over the past year was removed shortly before the hearing.
An FDA spokesperson said Sanjay Kaul, M.D., of Cedars-Sinai Medical Center in Los Angeles, may have given the appearance of having a conflict of interest. No more details were given.
The FDA didn’t invite the Safety and Risk Management Committee to the meeting with the Cardiovascular and Renal Drugs panel to discuss the pros and cons of prasugrel. Safety panelists have been convened for several other drugs in joint FDA meetings over the past year.
Insider wonders what Sid Wolfe has to say about prasugrel........