Ab­b­Vie's Qulip­ta adds FDA ap­proval for chron­ic mi­graine

Ab­b­Vie’s mi­graine drug Qulip­ta has net­ted FDA ap­proval for an­oth­er in­di­ca­tion.

On Tues­day, the Illi­nois phar­ma an­nounced the FDA ap­proved an ex­pand­ed in­di­ca­tion of the cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) for the pre­ven­ta­tive treat­ment of chron­ic mi­graines in adults. Qulip­ta is a once-dai­ly oral drug ini­tial­ly ap­proved in 2021 for pre­vent­ing episod­ic mi­graines in adult pa­tients.

Qulip­ta’s la­bel ex­pan­sion in chron­ic mi­graines is based on Ab­b­Vie’s Phase III tri­al, called Progress, eval­u­at­ing the drug in an adult pop­u­la­tion at a 60 mg dosage against a place­bo. The tri­al hit its end­point show­ing sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in mean months of mi­graine days (MMDs) against a place­bo. The tri­al al­so met sev­er­al sec­ondary end­points as well.

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