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Vertex's Symdeko (tezacaftor/ivacaftor and ivacaftor) Receives TGA's Approval for Cystic Fibrosis with CFTR Gene Mutation in Australia

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Vertex's Symdeko (tezacaftor/ivacaftor and ivacaftor) Receives TGA's Approval for Cystic Fibrosis with CFTR Gene Mutation in Australia

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  • The approval is based on P-III EVOLVE & EXPAND studies result assessing Symdeko vs PBO in 750 patients with CF having two copies of the F508del mutation or with one F508del mutation & residual CFTR activity aged> 12yrs.
  • The P-III EVOLVE & EXPAND studies demonstrated improvement in lung function- mean absolute change in ppFEV1 (4.0% vs 6.8%) and was well tolerated. It was published in New England Journal of Medicine in Nov’17
  • Symdeko is a combination therapy of tezacaftor/ivacaftor + ivacaftor and has received US FDA’s- Health Canada- EU’s approval in Feb’18- Jun’18 & Oct’18 respectively for the same indication

Ref: Vertex | Image: Vertex

Click here to­ read the full press release 

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