- That FDA approved Vertex Pharmaceuticals Incorporated VRTX Orkambi (lucaftor/ivacaftor) for extended use in children with cystic fibrosis (CF) aged 12 to < 24 months.
- The approval applies to infants who are homozygous for the F508del Mutation in cystic fibrosis transmembrane conductance regulator gene.
- See also: FDA lifts clinical eligibility on Vertex Pharma’s stem cell-derived diabetes treatment study.
- Orkambi was previously approved by the FDA for use in people with CF ages two years and older with two copies of the drug F508del Mutation.
- Orkambi was first approved in the US in 2015 and is now available in more than 30 countries.
- Price promotion: VRTX shares are down 2.23% to $283.74 on the most recent check Friday.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
