This site is intended for health professionals only

Atogepant approved by FDA for episodic migraine

Atogepant is the first calcitonin gene-related peptide (CGRP) receptor antagonist approved for the treatment of episodic migraine.

Migraine is estimated to globally affect 1 in 7 people and is two-to three times more common in women. The predominant symptom in migraine is an intensive and unilateral, moderate to severe throbbing headache. As well as a headache, migraine sufferers can also experience nausea and some also have visual symptoms (migraine with aura). The term episodic migraine, is used to define a headache frequency of less than 15 days per month. Acute treatment of migraine 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 3, 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 60 mg 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

Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine