Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

The FDA hands Farx­i­ga 'break­through' sta­tus in CKD, clear­ing path for As­traZeneca's much-tout­ed ther­a­py

As­traZeneca has been promis­ing big things on Farx­i­ga in kid­ney dis­ease since March, when they stopped a Phase III tri­al over what they deemed “over­whelm­ing ef­fi­ca­cy.” R&D chief Mene Pan­ga­los said it had the “po­ten­tial to change the man­age­ment of chron­ic kid­ney dis­ease for pa­tients around the world.”

Now, with de­tailed da­ta from that study out, the FDA has sig­naled it agrees with that as­sess­ment. They’ve hand­ed the drug a break­through des­ig­na­tion to treat pa­tients with chron­ic kid­ney dis­ease, re­gard­less of whether they have type 2 di­a­betes — the orig­i­nal dis­ease for which Farx­i­ga was ap­proved back in 2014.

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