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April 28, 2022

AAN 2022: Ubrelvy real-world efficacy in migraineurs with treatment failure

AbbVie’s Ubrelvy has been found to cause high satisfaction in achieving pain relief and the ability to think clearly in patients.

By GlobalData Healthcare

At the American Academy of Neurology (AAN) 2022 Annual Meeting, AbbVie presented new data examining the real-world effectiveness of Ubrelvy (ubrogepant) for the acute treatment of episodic and chronic migraine in patients who had switched treatment due to prior treatment failure. The observational, cross-sectional, non-interventional UNIVERSE study was conducted in the US and involved the analysis of 302 adult respondents using Healint’s Migraine Buddy mobile application, who had self-reported having administered at least four total doses of Ubrelvy and at least one dose of Ubrelvy in the preceding 14 days of completing the 29-question survey. This data highlights that Ubrelvy treatment resulted in a high satisfaction in achieving pain relief, the ability to think clearly, and a return to normal function in patients who reported lack of efficacy as the reason for prior treatment failure.

The acute treatment of migraine is dominated by triptans, which are migraine-specific oral therapies that have been used for the past two decades. As such, triptans are considered the industry gold standard to relieve migraine headaches. But as triptans are 5-HT1B and 5-HT1D agonists that cause constriction of both the cranial and peripheral blood vessels, the drug class poses a substantial concern for patients at risk or with a history of cardiovascular disorders. In addition, key opinion leaders (KOLs) interviewed previously by GlobalData noted that the efficacy of triptans is moderate at best, with a proportion of patients suffering from triptan sensations: side effects that include dizziness and tightening of the chest and the jaw or the neck.

However, since receiving US Food and Drug Administration (FDA) approval in December 2019 for the acute treatment of migraine, Ubrelvy, a small molecule calcitonin gene-related peptide (CGRP) antagonist belonging to the gepant drug class, has stolen significant patient share from the triptan class and has changed the treatment paradigm. KOLs expressed that side effects from gepants were rare and that patients who did not tolerate triptan treatment were likely to tolerate gepants. As such, gepants such as Ubrelvy and Biohaven’s Nurtec (rimegepant) are considered the next option, after triptans, for acute migraine treatment. Ubrelvy has the first-to-market advantage among gepants for acute treatment of migraine and GlobalData forecasts that Ubrelvy and Nurtec will generate $842.8m and $609.0m, respectively, within the US migraine market by 2030.

In the UNIVERSE study data presented at the AAN 2022 Annual Meeting, Ubrelvy treatment was associated with high patient satisfaction for achieving pain relief. At two, four and 24 hours post-dose, 76.1%, 83.3% and 78.4% of patients, respectively, reported satisfaction with Ubrelvy for achieving pain relief. When compared with their prior acute treatments, 85.2% of patients self-reported the ability to think clearly with Ubrelvy, while 84.8% of patients were satisfied with their ability to return to normal activities after taking Ubrelvy. In addition, among the patients who reported lack of efficacy as the reason for prior acute treatment failure, 91.7% of patients indicated they were either ‘definitely’ or ‘likely’ going to continue Ubrelvy use.

AbbVie’s study also reviewed prior and concurrent acute medication usage in participants who switched to Ubrelvy due to a lack of efficacy with previous treatment. Analysis revealed a 37.9% decrease in the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and a 54.6% decline in triptan use, the largest difference among the drug classes assessed. This suggests that Ubrelvy has the potential to reduce the pill burden for migraineurs. This is particularly important as regular overuse of NSAIDs, paracetamol and triptans can result in medication overuse headaches and an increase in the number of monthly migraine days.

The UNIVERSE study provides early real-world evidence of some potential benefits of Ubrelvy in patients who experienced treatment failure due to lack of efficacy. This information will help inform drug developers of patients’ needs and help support physician prescription patterns in patients who do not respond to the gold standard triptan therapy. Due to the market entry of other triptan alternatives, including Eli Lilly’s Reyvow (lasmiditan), Biohaven’s Nurtec and Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate), which received FDA approvals in 2019, 2020 and last year respectively, the acute migraine market is steadily becoming more competitive.

In addition, in the acute migraine treatment space, GlobalData anticipates the launch of some new triptan and ergot alkaloid products over the next five years, as well as another gepant, Biohaven’s intranasal zavegepant, which is expected to launch in the US in Q3 2023. As such, real-world data will help to solidify Ubrelvy’s place in a crowded market and help with patient uptake.

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