Europeans vote down dry powder mannitol

A

average

New member
It appears our friends in Europe have decided that an 6 to 8 percent improvements in lung function (2 clinical trials) in over 600 CF patients over a 12 months is not an sufficient improvement in FEV1 to justify approving the dry powder for marketing approval in Europe.  You have to wonder why authorities are not supporting these decent increases in FEV1.  What am i missing?
Mannitol is a dry powder derived from suger, which have shown to be effective in moving mucus, when used twice daily over 6, 12 and 18 month periods.  Its quick to use, derived from a natural substance, and two to three times more effective than nebulized saline.
Why is this product being denied to Europeans?  I hope the FDA will be more  supportive.  There are too many drug companies, with complicated medical therapies, so no wonder a quasi natural product development is being blocked, and why is the CF Foundation not lending any support.  Do they have to much vested interested in other drug companies they are associated with? 
 
 
 
 
 
 
 
 
A

average

New member
It appears our friends in Europe have decided that an6 to 8 percent improvements in lung function (2 clinical trials)in over 600 CF patientsover a 12 months is not an sufficient improvementin FEV1 tojustify approving thedry powder for marketing approval in Europe.You have to wonder why authorities are not supportingthese decent increases in FEV1. What am i missing?
Mannitol is a dry powder derived from suger, which have shown to be effective in moving mucus, when used twice daily over 6, 12 and 18 month periods. Its quick to use, derived from a natural substance, and two to three times more effective than nebulizedsaline.
Why is this product being denied to Europeans? I hope the FDA will be more supportive. There are too many drug companies, with complicated medical therapies, so no wonder a quasi natural product developmentis being blocked, and why is the CF Foundation not lending any support. Do they have to muchvested interested in other drug companies they are associated with?
 
A

average

New member
<p>It appears our friends in Europe have decided that an6 to 8 percent improvements in lung function (2 clinical trials)in over 600 CF patientsover a 12 months is not an sufficient improvementin FEV1 tojustify approving thedry powder for marketing approval in Europe.You have to wonder why authorities are not supportingthese decent increases in FEV1. What am i missing?
<p>Mannitol is a dry powder derived from suger, which have shown to be effective in moving mucus, when used twice daily over 6, 12 and 18 month periods. Its quick to use, derived from a natural substance, and two to three times more effective than nebulizedsaline.
<p>Why is this product being denied to Europeans? I hope the FDA will be more supportive. There are too many drug companies, with complicated medical therapies, so no wonder a quasi natural product developmentis being blocked, and why is the CF Foundation not lending any support. Do they have to muchvested interested in other drug companies they are associated with?
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H

hmw

New member
This is disappointing, but I fail to see how the CFF has anything to do with the decision of that European group. Fortunately, Bronchitol IS already approved in Australia. From the limited amount I was able to find, Pharmaxis plans on appealing this ruling with the CHMP, and they still will be applying for the NDA here in the US, but as we know, that's a process that takes time.
 
H

hmw

New member
This is disappointing, but I fail to see how the CFF has anything to do with the decision of that European group. Fortunately, Bronchitol IS already approved in Australia. From the limited amount I was able to find, Pharmaxis plans on appealing this ruling with the CHMP, and they still will be applying for the NDA here in the US, but as we know, that's a process that takes time.
 
H

hmw

New member
This is disappointing, but I fail to see how the CFF has anything to do with the decision of that European group. Fortunately, Bronchitol IS already approved in Australia. From the limited amount I was able to find, Pharmaxis plans on appealing this ruling with the CHMP, and they still will be applying for the NDA here in the US, but as we know, that's a process that takes time.
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A

average

New member
I suppose what I'm saying is the CFF is a global advocacy body but doesn't appear to openly support new CF therapies unless it has a financial interest in them (ie Vertex, nebulized saline). This mannitol stuff seems to work, so why doesn't the CFF openly apply some advocacy pressure? Agree it does look like they are appealing the decision.
 
A

average

New member
I suppose what I'm saying is the CFF is a global advocacy body but doesn't appear to openly support new CF therapies unless it has a financial interest in them (ie Vertex, nebulized saline). This mannitol stuff seems to work, so why doesn't the CFF openly apply some advocacy pressure? Agree it does look like they are appealing the decision.
 
A

average

New member
I suppose what I'm saying is the CFF is a global advocacy body but doesn't appear to openly support new CF therapies unless it has a financial interest in them (ie Vertex, nebulized saline). This mannitol stuff seems to work, so why doesn't the CFF openly apply some advocacy pressure? Agree it does look like they are appealing the decision.
 
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