FYI- There's an expanded access program (EAP) compassionate use program available for the new triple combo, VX-445
As far as I know, it's not limited to US patients. (I think Ireland and UK are included, but other countries may be eligible).
It's difficult to get any information from Vertex.
In the past, their expanded access program has been limited to patients who have eligible mutations and those with:
FEV1 of less than 40% predicted OR decline of 20% predicted in a 6 month period and sustained for 1 month OR being evaluated for a lung transplant.
But I don't know if the EAP requirements are the same for VX-445.
https://www.vrtx.com/medicines/expanded-access#how-it-works
Unfortunately, you can't follow their instructions for finding out more about it by going to clinicaltrials.gov, because the EAP isn't listed as it's required to be, but you can e-mail them and ask about it.
United States
medicalinfo@vrtx.com
Canada
medicalinfoCA@vrtx.com
Latin America
medicalinfoLATAM@vrtx.com
Africa, Asia, Australia and Europe
vertexmedicalinfo@vrtx.com
Here's some general info. about expanded access:
https://www.fda.gov/news-events/public-health-focus/expanded-access
As far as I know, it's not limited to US patients. (I think Ireland and UK are included, but other countries may be eligible).
It's difficult to get any information from Vertex.
In the past, their expanded access program has been limited to patients who have eligible mutations and those with:
FEV1 of less than 40% predicted OR decline of 20% predicted in a 6 month period and sustained for 1 month OR being evaluated for a lung transplant.
But I don't know if the EAP requirements are the same for VX-445.
https://www.vrtx.com/medicines/expanded-access#how-it-works
Unfortunately, you can't follow their instructions for finding out more about it by going to clinicaltrials.gov, because the EAP isn't listed as it's required to be, but you can e-mail them and ask about it.
United States
medicalinfo@vrtx.com
Canada
medicalinfoCA@vrtx.com
Latin America
medicalinfoLATAM@vrtx.com
Africa, Asia, Australia and Europe
vertexmedicalinfo@vrtx.com
Here's some general info. about expanded access:
https://www.fda.gov/news-events/public-health-focus/expanded-access
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