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

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

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

Shots:

  • 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

Click here to read full press release/ article | Ref: Vertex | Image: Business Wire

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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