Expanded Access Program (Compassionate use) for VX-445 triple combo

[jricci]

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

 

[jricci]

There's also a facebook group that you can join where people have been sharing their experiences with VX-445 Expanded Access
https://www.facebook.com/groups/vx445compassionateuse/