Intarcia’s ITCA 650 device accepted as new drug application by FDA
The US Food and Drug Administration (FDA) has accepted the filing of a new diabetes drug application from Boston pharmaceutical company Intarcia Therapeutics.
The ITCA 650 is potential once-a-year type 2 diabetes treatment that has been in development since 2012.
The device is the size of a matchstick and works by delivering exenatide (sold under the market name Byetta), a GLP-1 analogue, continuously through a mini-pump system called DUROS, which is placed under the skin in the abdomen.
The ITCA 650 has been accepted as a New Drug Application (NDA) by the FDA, which is essentially pre-approval.
The device will now go through a second more substantive FDA review, and if it passes then the ITCA 650 device could become commercially available by the end of 2017.
NDA approval was granted following successful results from the 52-week FREEDOM-2 trial, which followed 535 adults with type 2 diabetes who were taking metformin.
The ITCA 650 device was found to produce better blood glucose levels and enable more weight compared to Januvia (sitagliptin), a separate type 2 diabetes drug.
The DUROS mini-pump, which Intarcia is also seeking FDA approval for, met targets set out in a previous three-year study, called the FREEDOM cardiovascular outcome trial, which measured risk for heart attacks, strokes and chest pain associated with ITCA 650.
In this study, the ITCA 650 was shown not to worsen heart health when compared to a placebo, and establishing the device’s role on heart health will feature in the next stage of FDA testing.
Image credit: Intarcia Therapeutics
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