Vertex‘s Orkambi (lumacaftor/ivacaftor) Receives Health Canada Approval for Cystic Fibrosis (CF) Aged 2 to 5 yrs.

 Vertex‘s Orkambi (lumacaftor/ivacaftor) Receives Health Canada Approval for Cystic Fibrosis (CF) Aged 2 to 5 yrs.

Vertex’s Kalydeco (ivacaftor) Receives Health Canada’s Approval for Cystic Fibrosis (CF) with CFTR Gene Mutation in Children Aged 12 to <24mos.

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

Click here to read full press release/ article | Ref: Vertex Pharmaceuticals | Image:Benzinga

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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