FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Ver­tex has clinched a pri­or­i­ty re­view for the all-im­por­tant cys­tic fi­bro­sis triple that will blaze the trail for treat­ing a large group of pa­tients un­helped by its cur­rent drugs.

FDA reg­u­la­tors have set a PDU­FA date of March 19, 2020, just a year af­ter the Boston biotech post­ed pos­i­tive Phase III re­sults show­ing that peo­ple with two F508del mu­ta­tions ex­pe­ri­enced sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in lung func­tion af­ter a 4-week reg­i­men of VX-445, teza­caftor and iva­caftor. Af­ter re­view­ing 24-week da­ta among pa­tients with one F508del mu­ta­tion and one min­i­mal func­tion mu­ta­tion — and thor­ough­ly com­par­ing the VX-445 triple with an­oth­er com­bo fea­tur­ing VX-659 on scores like safe­ty, drug-drug in­ter­ac­tions, and pho­to­sen­si­tiv­i­ty — Ver­tex ul­ti­mate­ly went with VX-445.

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