Ver­tex un­veils cys­tic fi­bro­sis da­ta, talks of us­ing pri­or­i­ty re­view vouch­er

Ver­tex will use a pri­or­i­ty re­view vouch­er this year to speed the re­view of its next-gen­er­a­tion cys­tic fi­bro­sis can­di­date known as the “van­za triple” pro­gram.

Piv­otal da­ta re­leased on Mon­day sup­port the com­bi­na­tion ther­a­py as a po­ten­tial­ly more ef­fec­tive and con­ve­nient ver­sion of Ver­tex’s cur­rent­ly ap­proved Trikaf­ta, which gen­er­at­ed more than $9.8 bil­lion in 2023 sales. The com­pa­ny plans on fil­ing for ap­proval in the US by mid-2024, and it will use a pri­or­i­ty re­view vouch­er to short­en the re­view time from 10 months to six months, ex­ec­u­tives said on a fourth-quar­ter earn­ings call on Mon­day.

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