A source tells BNET that the FDA is sending out letters to drug companies giving them new guidelines for drug approvals in the diabetes category. The source says the FDA will now require a meta analysis of all phase II and phase III trials for cardiovascular events if the studies are still under way. Morgan Stanley put out an analysts’ note indicating that:
FDA, following a panel recommendation in July, is issuing generic letters to companies with diabetes drugs in development requiring pre-approval screening trials for CV risk, potentially followed by post-marketing studies. We understand that so far, such letters have been sent to sponsors with early-stage drugs.
If the data meets certain criteria, then companies may not have to do a long-term CV study, although a post-marketing study may still be required. The bottom line seems to be that more cardiovascular information is now required. The FDA told BNET:
At this time, we cannot confirm whether or not such letters are issuing.
If the source is correct, the new rules stem from the summer meeting that the FDA held on the topic. At that meeting, Steve Nissen of the Cleveland Clinic Foundation (and the curse of Avandia) urged tighter standards for CV events before new diabetes drugs were approved.
The acceptance of the new standards bolsters the case for Nissen as Obama’s new FDA chief.
David Kliff, author of the Diabetic Investor newsletter, said “I would not be shocked at all if that was happening [given recent events surrounding Avandia and CV risk] … quite honestly I totally expected this to happen.”
