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Highlights

  • ABBV’s Atogepant reduced discontinuation due to adverse events to 12.1% vs. 29.6% for Topiramate.
  • The Company met all six secondary efficacy endpoints in Phase 3 head-to-head TEMPLE trial.
  • ABBV reported 64.1% of patients on Atogepant achieved ≥50% reduction in migraine days.

AbbVie, Inc. (NYSE: ABBV) is a U.S.-based biopharmaceutical company headquartered in North Chicago, Illinois. The firm was spun off from Abbott Laboratories in 2013 and focuses on research and development across several therapeutic areas, including immunology, oncology, neuroscience, and eye care. AbbVie markets several major therapies, including Humira, Rinvoq, and Skyrizi, alongside QULIPTA/AQUIPTA for migraine.

The company has announced encouraging topline results from its Phase 3 TEMPLE clinical study, which evaluated its migraine prevention drug, Atogepant (marketed as QULIPTA/AQUIPTA), against topiramate, an established anticonvulsant also used for migraine prevention. The 24-week, randomized, double-blind, multicenter trial was conducted among adults who experience four or more migraine days per month.

Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist developed for the preventive treatment of migraine. The TEMPLE study compared a once-daily 60 mg dose of atogepant to a dose-optimized range of topiramate (50, 75, or 100 mg per day).

The primary endpoint of the study was treatment discontinuation due to adverse events. AbbVie reported that only 12.1% of patients on atogepant discontinued treatment due to side effects, compared to 29.6% in the topiramate group, suggesting better tolerability.

The study also achieved statistical significance across all six secondary endpoints, including critical measures of clinical efficacy. Most notably, during months four to six of the treatment period, 64.1% of patients taking atogepant achieved a ≥50% reduction in mean monthly migraine days, compared with 39.3% for patients on topiramate. This outcome reinforces atogepant’s effectiveness in reducing migraine frequency among chronic sufferers.

Other secondary endpoints, though not detailed in full by AbbVie, also demonstrated superior performance of atogepant over topiramate across multiple clinically relevant measures. The company said that the totality of data from this trial provides further support for the therapeutic profile of atogepant, particularly its efficacy and tolerability.

Both medications were administered according to established protocols, with patients randomized and blinded to the treatment arms. The topiramate dosage was adjusted to the highest tolerated level per patient, ensuring a fair comparison between the two treatments.

AbbVie noted that full results from the TEMPLE trial will be submitted for publication in a peer-reviewed journal and are expected to be presented at an upcoming scientific meeting. This recent Phase 3 trial underscores AbbVie's continued efforts in developing treatments for neurological conditions. If the data from the TEMPLE study are accepted by regulatory authorities, they may further influence prescribing trends for migraine prevention therapy globally.

The company plans to explore additional regulatory submissions and updates depending on the study’s final data and review timelines.