The JDRF today said it is encouraged that the Food and Drug Administration (FDA) has issued a draft guidance which appears to lay a foundation for accelerating the development and availability of artificial pancreas technology (AP) that will improve the lives of millions of Americans living with type 1 diabetes (T1D).
"Our initial review of the draft AP guidance indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field," said Jeffrey Brewer, President and CEO of JDRF. "It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP's safety and efficacy, and if that turns out to be the case it is good news."
Artificial pancreas technologies have the potential to be the most revolutionary advance in treating T1D since the discovery of insulin. They will allow the millions of Americans with T1D to maintain tighter control of blood glucose levels, thus significantly reducing the risk of both high blood sugar (hyperglycemia), which can cause long-term complications including heart disease, blindness and stroke, and low blood sugar (hypoglycemia), which can be life-threatening. It would also free them from much of the daily burden of managing the disease.
In 2006, the FDA added artificial pancreas technology to its Critical Path list, making a commitment to advance these systems. The draft guidance is the first step to getting the technology to those in dire need.
"To be sure, we have a ways to go before AP technologies are available to patients but this draft guidance suggests that Commissioner Hamburg and the FDA are committed to fostering innovation and being a global leader in bringing life-saving technologies for T1D patients to the U.S market," said Brewer. "In the next few weeks, we will review the draft guidance in detail and provide detailed comments to the FDA so that the final guidance unmistakably lays out the pathway to put AP technologies in patients' hands as soon as possible. In the end, that is what this is all about."
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