After having introduced an advanced diabetes treatment device to European and international patients in 2009, Medtronic (MDT) announced Friday that it has filed an application with the U.S. Food and Drug Administration that will bring the same therapy to the U.S. market.
With this submission, the FDA will review for the first time a diabetes continuous glucose monitoring system that will feature an automatic low glucose suspension capability. In other words, the continuous glucose monitoring pump has the ability to shut off pumping insulin into the bloodstream for two hours if the glucose values recorded by a sensor falls below a threshold.
A Medtronic spokeswoman could not say when FDA will grant an approval.
That automatic suspension functionality is considered a critical capability for the development of the artificial pancreas that will mimic the functioning of a normal, healthy pancreas.
In Europe and other nations, the approved product is called Paradigm Veo while in the U.S. it will be called MiniMed. In March, the company announced that patients using the Medtronic Paradigm Veo showed a 19 percent reduction in the amount of time spent below the low glucose threshold compared with conventional pump therapy. The study was done on patients in the clinic.
And now, the company is testing the safety and efficacy of this device in patients at home.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Meanwhile, two charitable foundations Juvenile Diabetes Research Foundation and the Helmsley Trust have pledged $17 million to Medtronic over three years to help fund a redundant sensor system that combines two sensing technologies in one CGM device, said Medtronic spokeswoman, Amanda Sheldon.
