FDA rejects Intarcia implanted-pump for Type 2 diabetes

This Boston start-up (Intarcia) is extremely well-funded ($600M), and has an unusual approach to Type 2 diabetes treatment: It has come out with a subcutaneous implanted pump, which pumps a GLP1 drug for 12 months at a time, which the FDA just bounced:

However, the rejection appears to be around manufacturing issues, and the company PR says that they don’t expect to need any more trials. They actually did really well in the two trials they had, which is in part why they were able to raise so much cash:

I was only peripherally aware of this venture and its pump, named the ITCA 650. So I was quite surprised to find out about it that way. Based on the circumstances (at least from what I have read), it seems that the FDA is likely to approve the pump without too much additional work for Intarcia.

Is there still a company that produces implanted insulin pumps for T1Ds? I heard that Medtronic is going to discontinue their production of implanted pumps.

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I think Medtronic’s Minimed implantable pump has been off the market for a long time (2007?) – but they still provide spare parts to a small number of clinics. There are only a few hundred PWDs wearing the device right now. I read a couple of articles on implantable pumps lately, I will try to find these articles and post them.

I think this GLP-1 pump is not really comparable to an insulin pump. It is “matchstick-sized osmotic mini pump that is the size of a match and is placed just beneath the skin to deliver a continuous and consistent flow of medication for a year”

Because the amount of GLP-1 is so small the pump is tiny and designed to put out a constant flow. Very different from the size and complexity of an insulin pump. Designed for patients who are squeamish about giving themselves an injection, since there are already daily or weekly injections of GLP-1 available.


I posted some of my recent readings on that here: