FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes

Cardiovascular risk associated with diabetes has been a major issue for those developing medications for diabetics.  Yesterday, the FDA issued a press release about new diabetes drug development guidelines that the agency is issuing in relation to the evaluation of CV risks.  The point is that the agency is officially stating that manufacturers of new treatments for Type 2 diabetes include evidence of CV risk evaluation as part of the NDA.  In other words, manufacturers must now proactively seek and comfort respecting CV risks associated with the drug.  It also signals a need on the part of manufacturers to address such issues in their pre-approval communications so that CV issues are clearly tracked ahead of filing an NDA, rather than waiting for an actual decision at FDA. 


From the release:

The guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required. Specifically, the guidance recommends that these studies demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies — especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.

The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.

Manufacturers of other treatments for other difficult drug development categories might take note and apply these standards in their own drug development proactively.  In other words, developers of anti-depressants should use the same methods recommended such as use of outside experts to assess suicidality.  Compound with a QT prolongation issue do the same.   By not waiting for a guidance, a manufacturer can go a long way to reassuring the agency.  And by communicating that a company is taking such steps, the corporate folks signal a company that is willing to be proactive and take all measures related to risk, which is great for the corporate brand.


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