Will the JDRF serve as an ally in getting approval?
Mar 31, 2014 9:40:10 GMT -5
liane and goyocafe like this
Post by jlaw277 on Mar 31, 2014 9:40:10 GMT -5
Given Sansum's recent success testing the artificial pancreas utilizing Afrezza, and the fact that the JDRF is actively bringing pressure to bear on the FDA regarding getting an AP to market, I would think that the two would provide a powerful combination in contributing towards getting Afrezza approved. Shouldn't this recent real-world third party utilization (and endorsement) of Afrezza contribute meaningfully to the ADCOM discussion?
Sansum/JDRF Artificial Pancreas
Article detailing JDRF's campaign to get an artificial pancreas to market
"Dr. Zisser stated: “Our preliminary results on the artificial pancreas working in tandem with the administration of mealtime ultra-fast-acting inhaled insulin are most promising. It’s very straightforward to load the inhaler device and take the insulin. There’s no needle involved and the small dose of inhaled insulin prevents the blood glucose from uprising very quickly just after eating or falling too fast an hour or two later. In this way, the subcutaneous insulin being supplied by the artificial pancreas’ pump has the chance to actually work better.”
"Co-principal investigator Francis J. Doyle, III, professor of chemical engineering, Mellichamp chair in process control, and associate dean of research at UCSB explained that “The subcutaneous route of delivery is a very slow way to push insulin into the body, compared to the appearance of glucose in the blood stream following the meal. So we need a much quicker way to intervene. One way to do that is to dose with the pump, but again, you’re using a subcutaneous route of pushing insulin, which is slow compared to the way the pancreas would do this. So, by using inhaled, ultra- rapid-acting insulin, we have a chance now to manage blood glucose even better by emulating a more natural pancreatic function. We can get the insulin quickly into circulation and it will be cleared quickly and safely from the bloodstream.”
Aaron Kowalski, Ph.D., vice president of treatment therapies at JDRF, remarked that “The early results of this exciting study are compelling. While more data are required, this protocol represents a potentially revolutionary way of combining the artificial pancreas with a simple-to-use inhaled insulin to significantly improve blood sugar levels. We are excited that Sansum Diabetes and UCSB researchers are working together with us and continuing to push the frontiers of diabetes research forward to benefit the quality of life for people living with the disease.”
Sansum/JDRF Artificial Pancreas
Article detailing JDRF's campaign to get an artificial pancreas to market
"Dr. Zisser stated: “Our preliminary results on the artificial pancreas working in tandem with the administration of mealtime ultra-fast-acting inhaled insulin are most promising. It’s very straightforward to load the inhaler device and take the insulin. There’s no needle involved and the small dose of inhaled insulin prevents the blood glucose from uprising very quickly just after eating or falling too fast an hour or two later. In this way, the subcutaneous insulin being supplied by the artificial pancreas’ pump has the chance to actually work better.”
"Co-principal investigator Francis J. Doyle, III, professor of chemical engineering, Mellichamp chair in process control, and associate dean of research at UCSB explained that “The subcutaneous route of delivery is a very slow way to push insulin into the body, compared to the appearance of glucose in the blood stream following the meal. So we need a much quicker way to intervene. One way to do that is to dose with the pump, but again, you’re using a subcutaneous route of pushing insulin, which is slow compared to the way the pancreas would do this. So, by using inhaled, ultra- rapid-acting insulin, we have a chance now to manage blood glucose even better by emulating a more natural pancreatic function. We can get the insulin quickly into circulation and it will be cleared quickly and safely from the bloodstream.”
Aaron Kowalski, Ph.D., vice president of treatment therapies at JDRF, remarked that “The early results of this exciting study are compelling. While more data are required, this protocol represents a potentially revolutionary way of combining the artificial pancreas with a simple-to-use inhaled insulin to significantly improve blood sugar levels. We are excited that Sansum Diabetes and UCSB researchers are working together with us and continuing to push the frontiers of diabetes research forward to benefit the quality of life for people living with the disease.”
