Application for Triple-Combination Therapy Submitted to the FDA

Vertex Pharmaceuticals Inc. announced today that it submitted a New Drug Application to the U.S. Food and Drug Administration for the approval of the first triple-combination therapy for cystic fibrosis.

July 22, 2019 | 1 min read

Today, Vertex announced that it has submitted a New Drug Application to the FDA for the approval of its triple-combination therapy -- elexacaftor (VX-445), tezacaftor, and ivacaftor.  Vertex confirmed it is seeking priority review, which, if granted by the FDA, would shorten the regulatory review to eight months from the time of submission versus the standard review time of one year. Topline results from the Phase 3 trial that was the basis of Vertex's application were announced earlier this year.

For additional information, please see the Vertex press release.

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