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.