As­traZeneca block­buster Farx­i­ga adds new heart in­di­ca­tion to la­bel

As­traZeneca said Tues­day that the FDA has ap­proved As­traZeneca’s Farx­i­ga (da­pagliflozin), an oral SGLT2 in­hibitor, for a la­bel ex­ten­sion to re­duce the risk of car­dio­vas­cu­lar death, hos­pi­tal­iza­tion for heart fail­ure and ur­gent heart fail­ure vis­its in adults with heart fail­ure.

The com­pa­ny said that FDA ap­proved the ex­ten­sion based on da­ta from a Phase III tri­al that showed the drug met the pri­ma­ry end­point, a sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful ear­ly re­duc­tion of car­dio­vas­cu­lar death or wors­en­ing heart fail­ure in pa­tients with cer­tain types of heart fail­ure.

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