D'Mine: just filed for regulatory approval in Brazil, 2-unit
Oct 15, 2017 2:37:01 GMT -5
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Post by lakers on Oct 15, 2017 2:37:01 GMT -5
Afrezza News: Could New Labeling Change the Game?
Written by Mike Hoskins and Amy Tenderich
Published on October 10, 2017
www.healthline.com/diabetesmine/afrezza-inhaled-insulin-new-labeling
Excerpts follow.
The Future for Afrezza (?)
With recent news of Novo's Fiasp approval helping MannKind compare the fast action of both insulins, and with both Dexcom CGM and the newly-approved Abbott FreeStyle Libre allowing more real-time data comparison, Castagna sees this as an especially exciting time for this Afrezza label change to happen.
"It's important for us," he says. "While it may seem simple on the surface, I would highlight that just being able to understand what a 4-unit cartridge does... is key. It's the first time a doctor will be able to really see and understand, and that's really important when you think of your child or loved one going to bed, and not seeing nocturnal hypoglycemia or sugars running high. To be able to know your sugars will comfortably come down over a certain period of time is really important. We think that's critical as we go forward."
Aside from these label changes, MannKind says it also recently dosed its first pediatric patient in the clinical trials setting (in collaboration with JDRF), and is exploring a 2-unit cartridge as a possibility for kids down the road. The company also just filed for regulatory approval in Brazil, as the first international country to start selling this inhaled insulin globally.
Importantly, MannKind also said it's continuing conversations with payers for increased access, and the company expects this label change to help motivate more payers to put Afrezza on the formulary for patients. Improved access will be a crucial step in all of this, Castagna says.
We're happy to hear of this progress for MannKind, and hope for the best on everything related to Afrezza. This product works well for us (both 'Mine editor AmyT and I myself use it), and we certainly continue keeping our fingers crossed that Afrezza becomes an option for anyone who wants it. Whether this label change is really the trigger remains to be seen.
Written by Mike Hoskins and Amy Tenderich
Published on October 10, 2017
www.healthline.com/diabetesmine/afrezza-inhaled-insulin-new-labeling
Excerpts follow.
The Future for Afrezza (?)
With recent news of Novo's Fiasp approval helping MannKind compare the fast action of both insulins, and with both Dexcom CGM and the newly-approved Abbott FreeStyle Libre allowing more real-time data comparison, Castagna sees this as an especially exciting time for this Afrezza label change to happen.
"It's important for us," he says. "While it may seem simple on the surface, I would highlight that just being able to understand what a 4-unit cartridge does... is key. It's the first time a doctor will be able to really see and understand, and that's really important when you think of your child or loved one going to bed, and not seeing nocturnal hypoglycemia or sugars running high. To be able to know your sugars will comfortably come down over a certain period of time is really important. We think that's critical as we go forward."
Aside from these label changes, MannKind says it also recently dosed its first pediatric patient in the clinical trials setting (in collaboration with JDRF), and is exploring a 2-unit cartridge as a possibility for kids down the road. The company also just filed for regulatory approval in Brazil, as the first international country to start selling this inhaled insulin globally.
Importantly, MannKind also said it's continuing conversations with payers for increased access, and the company expects this label change to help motivate more payers to put Afrezza on the formulary for patients. Improved access will be a crucial step in all of this, Castagna says.
We're happy to hear of this progress for MannKind, and hope for the best on everything related to Afrezza. This product works well for us (both 'Mine editor AmyT and I myself use it), and we certainly continue keeping our fingers crossed that Afrezza becomes an option for anyone who wants it. Whether this label change is really the trigger remains to be seen.
