AbbVie's Migraine Drug Outperforms Generic Treatment In Head-To-Head Trial

AbbVie Inc ABBV on Wednesday released topline results from its Phase 3 TEMPLE study evaluating the tolerability, safety, and efficacy of atogepant (QULIPTA/AQUIPTA, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.

The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention.

Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41.

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The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001). 

Atogepant, marketed as AQUIPTA in the EU and QULIPTA in the U.S., Canada, Israel, and Puerto Rico, is approved in 60 countries. It is a once-daily oral CGRP receptor antagonist used to prevent episodic and chronic migraine in adults.

Full results from the TEMPLE study will be presented at an upcoming medical meeting.

Recently, AbbVie said the Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival with a hazard ratio of 0.908; stratified log-rank, p=0.3772. No new safety signals were observed.

Price Action: ABBV stock is trading higher by 0.48% to $186.36 at last check Wednesday.

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