Vertex’s Kalydeco (ivacaftor) Receives FDA’s Approval for Cystic Fibrosis in Eligible Infants Aged 6 to Less than 12 Months

 Vertex’s Kalydeco (ivacaftor) Receives FDA’s Approval for Cystic Fibrosis in Eligible Infants Aged 6 to Less than 12 Months

Vertex’s Kalydeco (ivacaftor) Receives FDA’s Approval for Cystic Fibrosis in Eligible Infants Aged 6 to Less than 12 Months

Shots:

  • The approval is based on P-III ARRIVAL study results assessing Kalydeco (ivacaftor) in 11 children with CF aged 6mos. to <12 mos. with 1/10 mutations in the CFTR gene for 24wks.
  • The P-III ARRIVAL study results: mean baseline sweat chloride (101.5 mmol/L); @24wks. mean sweat chloride level (43.1 mmol/L); mean absolute change (-58.6 mmol/L); no patient discontinued therapy due to adverse events
  • Kalydeco (ivacaftor, 25,50,75,150 mg) is an oral CFTR potentiator enables the longer opening of CFTR protein at the cell surface to improve the transport of salt and water across the cell membrane and is approved in the US, Canada and EU for the treatment of CF in patients aged >12mos.

Click here to read full press release/ article | Ref: Vertex | Image: Cystic Fibrosis News Today

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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