At the American Academy of Neurology (AAN) 2024, AbbVie highlighted the long-term safety data of Qulipta (atogepant) for the preventive treatment of migraine in two different presentations. Qulipta was first approved by the FDA in 2021 for the preventive treatment of episodic migraine in adults, and this has since been expanded to include chronic migraine, and approval in Europe in 2023.
In the preventive market, treatment aims to reduce the frequency, severity, or duration of attacks. Beta-adrenergic receptor blockers, calcium antagonists, antidepressants, and anti-epileptics are all drug classes used in the prevention of migraines; however, only a few are specifically developed and approved for the treatment of migraines, with the remainder prescribed off-label. Some of the oral preventive treatments have been associated with potential adverse events (AEs) or are contraindicated, which may interfere with concurrent conditions and treatments; for example, amitriptyline is associated with a high risk of weight gain and topiramate is contraindicated in young females due to teratogenic effect and interference with oral contraceptives. Therefore, when taken daily, these drugs lead to various AEs that often cause patients to not be fully compliant with treatment or to discontinue treatment. Furthermore, key opinion leaders (KOLs) previously interviewed by GlobalData reported that low efficacy of oral preventive treatment was common among patients, meaning that patients often cycle through the different drug classes of oral preventive treatments.
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On 15 April at AAN 2024, during a scientific platform session titled “Emerging Science”, AbbVie presented interim results from a Phase III open-label study (NCT04686136) evaluating the long-term safety and efficacy of Qulipta for migraine prevention in episodic and chronic migraine. The interim safety data showed that once-daily administration of Qulipta for 48 weeks has a safety profile consistent with all previous studies of the drug with no new safety concerns emerging. Additionally, the efficacy outcomes seen in the Phase III PROGRESS trial (NCT03855137) and the Phase III ELEVATE trial (NCT04740827), which the trial participants had completed before entering the open-label study, were consistent over the 48-week extension study.
On 16 April at AAN 2024, in a session titled “Advances in Migraine and Therapeutics”, AbbVie presented further safety data relating to Qulipta. Topline data from the Phase IV TANDEM trial (NCT05264129) evaluating Qulipta monotherapy for 12 weeks, followed by the combination of Qulipta taken once daily for migraine prevention with AbbVie’s Ubrelvy (ubrogepant) taken when required for acute migraine treatment for 12 weeks, was presented. Overall, the safety of Qulipta was again consistent with previous clinical trials, and the combination of the two gepants was found to be well tolerated. It was highlighted that there were no hepatic safety concerns related to the gepant combination over 12 weeks of treatment with no patients discontinuing due to elevations in alanine transaminase (ALT) or aspartate transaminase (AST).
These results, combined with continued evidence of long-term safety at the end of the 156-week-long open-label Phase III trial (NCT04686136), will be imperative to instill confidence in the daily administration of gepants for prophylactic migraine treatment given that previous safety issues concerning hepatoxicity for Merk’s gepants, telcagepant and MK-0974, had originally proven to be a setback for the development of other drugs in the gepant class. Despite the strong efficacy and safety data regarding Qulipta, it is still possible that the beta-adrenergic receptor blockers, antidepressants, and anti-epileptic drugs will remain the first line of migraine prevention therapy as they are widely available as generics and reimbursement of the newer, more expensive gepants will be a barrier for first-line treatment in some countries.
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