Vertex's Orkambi (lumacaftor/ivacaftor) Receives Health Canada Approval for Cystic Fibrosis (CF) Aged 2 to 5 yrs.
Shots:
- The approval is based on P-III study results assessing Orkambi in 60 patients with CF- who have two copies of the F508del CFTR mutation aged 6 to 11 years for 24 wks.
- The P-III study demonstrated in reduction of sweat chloride by 31.7 mmol/L and was well-tolerated- Presented at European Cystic Fibrosis Society Conference in June 2018
- Orkambi is a combination of lumacaftor + ivacaftor used for targeting F508del CFTR protein and is approved by the US FDA for CF aged 2 to 5 yrs. in Aug- 2018
Ref: Vertex Pharmaceuticals | Image: Vertex
Tags
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com