Ab­b­Vie, Lund­beck ask FDA to re­vise draft guid­ance on mi­graine drugs

Af­ter the FDA pub­lished draft guid­ance in June on de­vel­op­ing drugs to help pre­vent mi­graines, two com­pa­nies in this space are ask­ing the agency to re­vise parts of the guid­ance to bet­ter ac­count for pe­di­atric pop­u­la­tions and clar­i­fy the dif­fer­ences be­tween chron­ic and episod­ic mi­graines.

The draft guid­ance laid out con­sid­er­a­tions for pre­ven­tive mi­graine drug­mak­ers, in­clud­ing guide­lines on ex­pect­ed tri­al pop­u­la­tion, con­comi­tant med­ica­tions and ef­fi­ca­cy end­points. The guid­ance for pre­ven­tive treat­ment came af­ter the agency pub­lished fi­nal guid­ance in 2018 on med­ica­tions for the treat­ment of acute mi­graines.

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