AbbVie’s migraine drug scores another Phase III win
Published: Apr 21, 2023
By Kate Goodwin
Kicking off this year’s American Academy of Neurology annual meeting on Friday morning, AbbVie shared more positive results for its migraine drug, Qulipta (atogepant).
Originally approved in 2021 for the preventative treatment of episodic migraine headaches, AbbVie has continued to add indications for its CGRP receptor antagonist. On Tuesday, AbbVie won approval from the FDA to expand the drug’s label further to include chronic migraine.
New results from another Phase III trial studying the drug demonstrated its efficacy for treating episodic migraine in patients for which two to four classes of conventional medications have failed.
In the ELEVATE study, Qulipta decreased patients’ mean monthly migraine days by 4.2 days, a significant reduction to the 1.85 days seen in the placebo arm over the 12-week treatment period.
CGRP receptor antagonists are the first class of migraine drugs that show similar efficacy to triptans, without vasoconstrictive activity and with fewer side effects. Triptans should not be used by patients with a history or risk factors for heart disease, high blood pressure and other common health conditions, making drugs like Qulipta an important option.
AbbVie’s drug is now the only oral CGRP receptor antagonist approved as a preventive treatment for both episodic and chronic migraine frequencies. The once-daily oral medication has only been approved in the U.S. at this point.
AbbVie has three treatments available for migraine in its neuroscience portfolio – its second-highest earner after its immunology drugs. Botox Therapeutic, Ubrelvy and Qulipta collectively brought in revenues of over $3 billion in the U.S. in 2022.
The migraine drug market is massive, affecting over 1 billion people worldwide every year. It’s one of the highest causes of disability in adults under 50.
Last spring, Pfizer made a play into the migraine market when it dropped $11.6 billion to acquire Biohaven. Its bet paid off in March, when the FDA approved its nasal spray Zavzpret (zavegepant) for the acute treatment of migraine in adults.
Zavzpret is the first CGRP antagonist nasal spray on the market for migraines, having demonstrated significantly higher rates of pain relief, durability and return to normal function compared to placebo. An oral formulation of the drug is in Phase II for migraine prevention, a market where it could contend with AbbVie’s Qulipta.