AbbVie charts a new course for CGRPs in menstrual migraine

AbbVie's Qulipta has become the first oral CGRP inhibitor to show efficacy in a phase 3 study involving women with menstrual migraine, which is severe and tends to resist current treatments.

Qulipta (atogepant) has already become a blockbuster treatment after being approved for headache prevention in both episodic and chronic forms of migraine, raking in more than $2.3 billion last year.

Moving into menstrual migraine prophylaxis, which affects millions of people in the US alone, could unlock another big market for Qulipta that is free from competition from other CGRP drugs.

In the LUNA study, Qulipta was compared to placebo in 468 adult female subjects prone to menstrual migraine, with the drug taken for seven consecutive days – starting three days before the onset of menses – over three menstrual cycles.

The topline data revealed by AbbVie shows that the average reduction in migraine days with Qulipta was 1.20 migraine days, versus 0.40 days with placebo, which the company said corresponded to a statistically significant fall of 0.80 days compared to control. Without going into details, the company said that the CGRP inhibitor also met all secondary endpoints in the trial.

AbbVie said it intends to share the results with regulators to see if the label for Qulipta can be extended to include menstrual migraine, which by some estimates affects around 12 million women in the US alone.

It is one of the reasons why women are affected by migraine three times more often than men, as studies show that up to two-thirds of women who experience regular migraines report attacks tied to their menstrual cycle.

Survey data from the European Migraine and Headache Alliance Migraine in Women Survey suggests that menstrual migraines are more painful, longer-lasting, or more resistant to medication than non-menstrual attacks, while 68% reported they had never been offered a tailored treatment approach.

"Menstrual migraine attacks can be severe, long-lasting, and disruptive to daily life," commented Primal Kaur, AbbVie's head of global development for immunology, neuroscience, eye care, and specialty medicines.

"[This] data bring[s] us closer to our goal of bringing a potential treatment option for women living with this debilitating disease," she added.

AbbVie's closest rival in the market for oral CGRPs for migraine prevention, Pfizer, is also running a phase 3 trial of its Nurtec ODT (rimegepant) product in menstrual migraine.