Vertex Pharma: FDA Approves Expanded Use of Trikaftato in Children

By Michael Dabaie

Vertex Pharmaceuticals Inc. said Wednesday the U.S. Food and Drug Administration approved expanded use of Trikaftato in children.

The company said the FDA approved expanding use to include children with cystic fibrosis ages 6 through 11 years with certain mutations.

Vertex completed a Phase 3 study which enrolled 66 children ages 6 through 11 years old with cystic fibrosis. The regimen was generally well tolerated, and safety data were similar with those observed in previous studies of patients ages 12 years and older.

"We can now reach approximately 1,500 newly eligible children in the U.S., and we continue to pursue approval for this expanded indication in other countries," said Chief Executive Reshma Kewalramani.

Shares were up 1.3%, to $213.85, in premarket trading.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

June 09, 2021 08:53 ET (12:53 GMT)

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