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Diabetes drug delays stir controversy


New preapproval safety data demands can mean millions of dollars and more years for development

WASHINGTON, D.C. - The Food and Drug Administration's requirement for more safety information on new diabetes treatments might start claiming victims among the sponsors. In addition to showing that a new type 2 diabetes drug lowers blood sugar, FDA guidance issued last December directs sponsors to study whether drugs also raise the risk of heart attacks and strokes.

Patient advocates and researchers are up in arms over this much higher hurdle for the more than 100 diabetes drugs under development. The new preapproval safety data demand will mean millions of dollars and more years for development, says Diabetes Close Up publisher Kelly Close.

Those sponsors who had completed trials and filed NDAs (new drug applications) before the guidance was finalized are in a bind. FDA recently indicated that it may not approve Takeda Pharmaceuticals' application for alogliptin, which was filed months ago, because of insufficient clinical data on cardiovascular risk. Other new diabetes treatments from Bristol-Myers Squibb and Novo Nordisk made it to the advisory committee review stage earlier this month, but additional pre- and post-market testing may be needed.

Diabetes is a huge market, generating $23 billion in global drug sales. At the Diabetes Forum sponsored by Avalere Health in March, Robert Heine, head of diabetes drug development at Eli Lilly, acknowledged that the FDA guidance may double the cost of development programs. The future, he said, lies in moving beyond glucose-lowering to products that can control the natural course of disease and better manage cardiovascular risk.

But Close and others consider FDA's regulatory environment too stringent for drugs that don't show any cardiovascular signals, and fear that manufacturers will be more likely to cancel development programs for drugs with any signs of cardiovascular events. We need "the right balance" at FDA between assuring safety and promoting innovation, Close commented.

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