Vertex Receives EU’s MAA for Symkevi (tezacaftor/ivacaftor) + Kalydeco (Ivacaftor) to Treat Patients with CF aged ≥12yrs. with Mutations in CFTR gene

 Vertex Receives EU’s MAA for Symkevi (tezacaftor/ivacaftor) + Kalydeco (Ivacaftor) to Treat Patients with CF aged ≥12yrs. with Mutations in CFTR gene

Vertex Receives EU’s MAA for Symkevi (tezacaftor/ivacaftor) + Kalydeco (Ivacaftor) to Treat Patients with CF aged ≥12yrs. with Mutations in CFTR gene

Shots:

  • The approval is based on the results of two P-III studies EVOLVE & EXPAND assessing Symkevi + Kalydeco vs PBO in 750 patients with CF having two copies of the F508del mutation or with one F508del mutation & a copy of either of 14mutations showing CFTR residual activity
  • P-III EVOLVE & EXPAND results: mean absolute change in ppFEV1 (4.0%, 6.8%); well tolerated. The combination is approved by the US FDA & Health Canada in Feb, 2018 & Mar, 2018 respectively and is marketed as Symdeko in the US and Canada
  • Symkevi is developed to detect mutations in CFTR gene. Additionally, EMA has recommended to maintain the Orphan Drug Designation for the combination

Click here to read full press release/ article | Ref: Vertex Pharmaceutical| Image: Boston Herald

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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