Vertex Says FDA to Review Applications for Expanded Use of Trikafta, Symdeko, Kalydeco

By Colin Kellaher

Vertex Pharmaceuticals Inc. on Tuesday said the U.S. Food and Drug Administration has accepted three applications seeking expanded approvals for Trikafta, Symdeko and Kalydeco in cystic fibrosis.

The Boston drug maker said it seeking expanded labeling of the drugs to include additional rare CFTR mutations, which would make more than 600 people with the mutations newly eligible for the medicines.

Vertex said the submissions may also allow certain cystic fibrosis patients who are currently eligible for Kalydeco to become eligible for Symdeko or Trikafta, and certain people currently eligible for Symdeko eligible for Trikafta.

Vertex said the FDA has set a target action date of Dec. 30 for the applications.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 01, 2020 09:37 ET (13:37 GMT)

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