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

[GenH]

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!

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=696069

 

[GenH]

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.

 

[cfsucks]

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!

 

[JENNYC]

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

That is fantastic news!!

 

[CyrilCrodius]

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!