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Vertex Pharma's Flagship Cystic Fibrosis Drug Scores FDA Approval For Infants

·1 min read
  • The FDA has approved Vertex Pharmaceuticals Incorporated's (NASDAQ: VRTX) Orkambi (lumacaftor/ivacaftor) for expanded use to include children with cystic fibrosis (CF) ages 12 to <24 months.

  • The approval covers infants who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.

  • Also see: FDA Lifts Clinical Hold On Vertex Pharma's Stem Cell-Derived Diabetes Treatment Trial.

  • Orkambi was previously approved by the FDA for use in people with CF ages two years and older with two copies of the F508del mutation.

  • Orkambi was first approved in 2015 in the U.S. and is now available in more than 30 countries.

  • Price Action: VRTX shares are down 2.23% at $283.74 on the last check Friday.

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