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I've added some info to my blog about why fat is needed with Kalydeco and also some info about the pharmacokinetics (such as how long it takes to metabolise Kalydeco). I've also copied some of the prescribing info and added some info from the FDA about medications which may interact with...
I just thought I would post some information about Bronchitol. Bronchitol has been available in Australia since August so I decided to do the challenge (first dose trial).
I've recently felt that pulmozyme and hypertonic work really well for me, so I was not expecting to find much improvement...
Hi everyone, I recently had sweat tests as I am on Kalydeco, and I was curious to find out about normal chloride values. I found that there is limited research looking at sweat chloride in non CFs over different age groups. However, one of the best quality studies found the following results...
Big news- new phase 2 study looking at Kalydeco and CFTR Mutations associated with residual CFTR function or defective mRNA splicing:
R117H, E56K, P67L, D110E, D110H, R117C, R347H, R352Q, A455E, D579G, S945L, L206W, R1070W, F1074L, D1152H, S1235R, D1270N, 2789+5G->A, 3849+10kbC->T...
Kalydeco gets EMA approval (Europe) & Vertex has applied to the TGA (Australia) and the TPD (Canada)
Kalydeco has been approved in Europe by the EMA. Vertex has also applied to the TGA in Australia and the TPD in Canada (priority review). Hopefully this means more of us can get it soon...
Just saw the trials for R117H and other gating mutations (G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D) on the clinicaltrials.gov...
<span class="commentBody" data-jsid="text"><span class="messageBody" data-ft="{"type":3}">Someone in the Kalydeco for Australians facebook group asked me to summarise the Ataluren press release and I thought I would paste it here as well: (sorry it is quite long, but it discusses a few things...
Over the last month a Named Patient Program has been developed in Australia and people below 40% FEV1 now have access to Kalydeco prior to TGA approval & PBS listing. The next step is TGA approval (like the FDA and EMA), hopefully Vertex will apply later this year. The TGA process is normally 9...
I am reposting my original post as the last topic has stopped working (cant read the bottom few posts, I have emailed the website and it has not changed).
"A few weeks ago I went to the TGA website and saw that Kalydeco was listed as an orphan drug but not listed on the TGA. I phoned the TGA...
I just posted this on the Australian forums but hardly anyone seems to post/visit the website, so I am posting here as well:
A few weeks ago I went to the TGA website and saw that Kalydeco was listed as an orphan drug but not listed on the TGA. I phoned the TGA to find out if Vertex had applied...
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