The approval of two migraine drugs, QULIPTA (atogepant) and Aimovig (erenumab-aooe), by the U.S. Food and Drug Administration (FDA), has expanded the available therapy options for patients suffering from episodic and chronic migraines.
The main cause of migraine is due to CGRP release outside the brain, which causes inflammation and blood vessel dilation, leading the blood vessels to increase in size – the combination of inflammation and vasodilation results in migraine pain. When a patient suffers from a migraine or moderate to severe headache, there are associated symptoms like light and sound sensitivity, cognitive dysfunction, gastrointestinal symptoms, fatigue, mood swings, and sometimes motor and visual symptoms.
The FDA has authorized the use of QULIPTA, a drug manufactured by AbbVie, for the preventative treatment of chronic migraine, a condition marked by 15 or more headache days per month, with at least 8 of those days meeting the migraine criteria. QULIPTA is the first orally administered pharmaceutical drug targeting the calcitonin gene-related peptide (CGRP) receptor pathway, in contrast to conventional migraine drugs.
Most of the CGRP antagonists were previously administered via injection or infusions; this drug is a substantial advancement in the field. For individuals who have a fear of needles or find it difficult to keep regular doctor's appointments, the approval of QULIPTA as an oral pill option provides simplicity and hope.
The FDA's approval, according to Dr. Peter McAllister, director of the New England Center for Neurology and Headache, is an important turning point as it offers chronic migraine sufferers a new, safe, and effective treatment option in the form of an easy, once-daily pill. The drug Aimovig is expected to cost $575 every month and $6,900 annually in the US.
Additionally, QULIPTA gives expecting mothers the option to cease the treatment and eliminate any remaining CGRP blockers from their system before conception. This is due to its unique property of being cleared from the body in a matter of days, compared to the several months it takes for antibodies used in other treatments to clear.
The PROGRESS clinical trials demonstrated the efficacy of QULIPTA, with individuals consuming 60 mg doses showing a decreased average of migraine days per month and a 40% decreased average over three months. According to the University of Calgary's Dr. Werner Becker, an emeritus professor of clinical neuroscience and medicine, even a 50% decrease in headache frequency is a major improvement and highlight for many patients. During clinical trials, QULIPTA's adverse effects, including nausea, constipation, and tiredness, were sometimes easily managed.
However, CGRP-targeting drugs like QULIPTA are promising for migraine therapy options due to the possibility of fewer adverse effects compared to older oral preventative medications.