Atogepant approved for treatment of episodic migraine

6th October 2021

Atogepant, the first and only calcitonin gene-related peptide (CGRP) receptor antagonist, has been approved by the FDA for the treatment of migraine

Migraine is a common health problem which has been estimated to globally affect 1 in 7 people and occurs two-to three times more often in women. The main symptom of migraine is an intensive, often unilateral, moderate to severe throbbing headache. In addition, sufferers can also experience nausea and vomiting and some experience migraine with aura which gives rise to visual symptoms. The term episodic migraine, is used to define headaches which occurs on less than 15 days per month.

Acute treatment involves the use of 5HT₁-receptor agonists (‘or triptans’) of which there are several e.g., sumatriptan. The underlying cause of migraine is unclear but calcitonin gene-related peptide (CGRP), a potent vasodilator, most likely plays an important role given how levels are increased during a migraine attack.

Studies suggest that blocking CGRP is therefore a potential treatment for episodic migraine and in fact, oral CGRP receptor antagonists (known as gepants) such as atogepant, represents a promising new therapy for migraine.

Clinical efficacy

The US FDA has approved the first and only gepant, atogepant (brand name Qulipta) for the preventative treatment of migraine in adults. The approval was based on a Phase III, double-blind trial in adults with an average of 4 to 14 migraine days per month. A total of 873 patients were randomised to atogepant 10, 30 and 60 mg (once daily) or placebo for 12 weeks and the primary endpoint was the change from baseline in the mean number of headache days per month. At week 12 there was a 55.6%, 58.7% and 60.8% reduction in the 3-month average of migraine days per month for the 10, 30 and 60mg atogepant groups respectively compared to 29% for the placebo arm (p < 0.001). All doses were well tolerated with the most common adverse effects including constipation (6.9 – 7.7% across doses) and nausea (4.4 to 6.1%).

Atogepant will be available from early October 2021.

Source. Abbvie Media News Centre