Kalydeco gets EMA approval (Europe) & Vertex has applied to the TGA (Australia) and the TPD (Canada)

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GenH

New member
Kalydeco gets EMA approval (Europe) & Vertex has applied to the TGA (Australia) and the TPD (Canada)

The orphan drug listing on the TGA says "for the treatment of cystic fibrosis (CF) in patients who have a gating or an R117H mutation in the CFTR gene," but Cystic Fibrosis Australia has clarified that the current TGA application is just for G551D.
 
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cfsucks

Guest
Kalydeco gets EMA approval (Europe) & Vertex has applied to the TGA (Australia) and the TPD (Canada)

Finally submitted to Canada- now I'm just worried about funding!- it's great if it's available but not if 95% of people with CF can't afford it!
 
J

JENNYC

New member
Kalydeco gets EMA approval (Europe) & Vertex has applied to the TGA (Australia) and the TPD (Canada)

That is fantastic news!!
 
C

CyrilCrodius

New member
I read that it successfully got a priority review status in Canada!

The normal review process can take up to 18 months. Damn, that is so slow! I wonder how long the priority review status makes it...

Once a product receives and NOC, it can take 6 to 10 months for it to be approved on the provincial level.

Edit : Priority review means that it should get a NOC within 180 (6 month) if everything goes well!

So Kalydeco should be pretty much available within... a year and a half... damnit, it takes so long!
 
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