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