I read that Savara has been granted “Breakthrough Therapy Designation“ for development and review of Molgradex for apap. Does anyone have more info on this and what are the differences between the two medicines?
3 comments
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clanpark
Dec 31, 2019
I don't have any more info on other than what I have read on the internet. The "Breakthrough Therapy Designation" will definitely help fast track the process to getting Molgradex FDA approved.
Gigi
Dec 31, 2019
Oh my thank you for the information. I heard there may be a shortage of Leukine due to the sale of the company, Sanofi. They sold the formula for making Leukine to a company in the United States. They should be up and running soon, hopefully the new medicine Molgradex will be less expensive. It is wonderful to here we all may have another option. Happy New Year to all and may we have a great Lung Year
Joseph Arsenault
Jan 02, 2020
Although Savara did receive Breakthrough Designation they will most likely have to run another PH III before potential approval, which will take years. They missed the primary endpoint on their recent PH III due to 4 patient outliers. Excluding those patients in the study that received supplemental oxygen, the study would have succeeded and most likely Molgradex will be on the market later this year,early next. There was clear signs of efficacy for aPAP patients, however the FDA seems to be steadfast on P-Values and not patient outcomes.Overall a tough break for aPAP patients.
I don't have any more info on other than what I have read on the internet. The "Breakthrough Therapy Designation" will definitely help fast track the process to getting Molgradex FDA approved.
Oh my thank you for the information. I heard there may be a shortage of Leukine due to the sale of the company, Sanofi. They sold the formula for making Leukine to a company in the United States. They should be up and running soon, hopefully the new medicine Molgradex will be less expensive. It is wonderful to here we all may have another option. Happy New Year to all and may we have a great Lung Year
Although Savara did receive Breakthrough Designation they will most likely have to run another PH III before potential approval, which will take years. They missed the primary endpoint on their recent PH III due to 4 patient outliers. Excluding those patients in the study that received supplemental oxygen, the study would have succeeded and most likely Molgradex will be on the market later this year,early next. There was clear signs of efficacy for aPAP patients, however the FDA seems to be steadfast on P-Values and not patient outcomes.Overall a tough break for aPAP patients.