An FDA advisory committee voted unanimously to recommend that prasugrel (Effient) be approved for preventing thrombosis in high-risk acute coronary syndrome patients after percutaneous coronary intervention.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.
But:
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.
Also:
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........
2 comments:
I thank you for posting this very much, yet with mixed emotions.
Eli Lilly progressively frightens me with my concerns for public health, as does the FDA.
I am more concerned as to what are Dr. Kaul’s true motives behind his bias against prasugrel...what are his ties to BMS & Plavix. How much have they paid him to put blood in the waters? Why would you not one a competitor for this high risk population especially with the strength of the data in a head to head study?
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