Vertex Pharmaceuticals (VRTX) said Friday that the US Food and Drug Administration granted expanded approval for Trikafta to children ages 2 or older with cystic fibrosis and certain of its genetic profiles.
The approval covers patients who have at least one F508del mutation or another mutation that responds to Trikafta, according to the company.
The FDA also updated safety information related to liver injury and liver failure to a boxed warning.
Vertex said the approval extends Trikafta's label with 94 new non-F508del cystic fibrosis transmembrane conductance regulator mutations.
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