Am­gen, No­var­tis are rac­ing to reg­u­la­tors with pos­i­tive PhI­II mi­graine da­ta, but ri­vals are in hot pur­suit

It ap­pears that Am­gen and its part­ners at No­var­tis are on a straight path to a new drug ap­proval for their new mi­graine drug erenum­ab. Six weeks af­ter in­ves­ti­ga­tors her­ald­ed the first Phase III suc­cess for this CGRP drug, Am­gen an­nounced to­day that the sec­ond late-stage tri­al was a hit as well.

In this sec­ond Phase III re­searchers test­ed a 70 mg and 140 mg dose in a tri­al that re­cruit­ed a to­tal of 955 pa­tients. Both dos­es came through, re­duc­ing the av­er­age num­ber of mi­graine days suf­fered by the groups at 3.2 days and 3.7 days, re­spec­tive­ly. The place­bo arm ex­pe­ri­enced a 1.8 day re­duc­tion in mi­graine days, start­ing off with a base­line of 8.3 days per month.

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