Qulipta (atogepant) / Merck (MSD), AbbVie - LARVOL DELTA

Comprehensive analysis of diagnostic biomarkers related to histone acetylation in acute myocardial infarction. (PubMed, BMC Med Genomics) - "AQP9, HLA-DQA1, MCEMP1, NKG7, and S100A12 were identified as biomarkers related to ARGs in AMI, which provides a new perspective to study the relationship between ARGs and AMI."

Biomarker • Journal • Cardiovascular • Myocardial Infarction • CD8 • HLA-DQA1 • NKG7 • S100A12

ECLIPSE: Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine (clinicaltrials.gov) - P3 | N=1300 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Migraine • Pain

AQUIPTA: a new drug for migraine prophylaxis [Google translation] (Vidal Vademecum Spain) - "AQUIPTA 10 mg and 60 mg tablets are two new specialties indicated for migraine prophylaxis in adults with at least 4 migraine days per month. They are available in hospitals and in the community, without reimbursement to date despite a favorable opinion issued by the Transparency Commission (CT) in a limited area...Despite a favorable opinion from the CT for coverage of AQUIPTA, this medication is not reimbursable as of April 8, 2025 due to the lack of a price agreement between the laboratory and the Economic Committee for Health Products (CEPS)....The recommended dose is 60 mg of atogepant once daily, or 1 tablet of AQUIPTA 60 mg per day. The tablet can be taken with or without food."

Reimbursement • Migraine

Impact of Atogepant on Functional Outcomes in Trial Completers for the Preventive Treatment of Episodic Migraine: A Post-Hoc Analysis of the ADVANCE Trial (S35.003). (PubMed, Neurology) - "Holle has nothing to disclose. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff."

Clinical • Journal • Retrospective data • CNS Disorders • Migraine • Pain

Post Hoc Analysis of ADVANCE Trial Reveals Atogepant Improves Functional Outcomes in Migraine (NeurologyLive) - "...a meta-analysis also presented at AAN 2025 provided further evidence supporting the efficacy of atogepant for migraine prevention. The analysis showed that atogepant not only reduced the frequency of migraines but also enhanced quality of life for patients, despite some adverse effects like constipation and nausea...The meta-analysis pooled data from 4 randomized controlled trials involving 2813 patients, with 1354 receiving atogepant. The trials collectively showed that atogepant significantly reduced monthly migraine days (SMD, -0.39; 95% CI, -0.49 to -0.29) and monthly headache days (SMD, -0.40; 95% CI, -0.51 to -0.30). Participants also reported decreased acute medication use (SMD, -0.44; 95% CI, -0.70 to -0.18), and a greater 50% responder rate (RR, 1.84; 95% CI, 1.40- 2.42) in the atogepant group compared with placebo."

Retrospective data • Migraine

Post Hoc Analysis of ADVANCE Trial Reveals Atogepant Improves Functional Outcomes in Migraine (NeurologyLive) - P3 | N=910 | ADVANCE (NCT03777059) | Sponsor: Allergan | "A post hoc analysis of the ADVANCE trial (NCT03777059) revealed that 60 mg once daily of atogepant (Qulipta; AbbVie) led to significant improvements in functional outcomes in patients with episodic migraine...The analysis focused on participants who completed at least 84 days of treatment and had valid data for all study visits. Presented at the 2025 American Academy of Neurology (AAN) Annual Meeting, held April 5-9, in San Diego, California, a total of 176 participants in the atogepant group and 178 in the placebo group were included...The study reported that participants receiving atogepant showed greater improvements from baseline in the MSQv2.1 domains compared with placebo at week 4. Notable improvements included Role Function Restrictive (LSMD change from baseline, 14.25; 95% CI, 9.70-18.81), Role Function Preventive (LSMD, 10.19; 95% CI, 6.01-14.37), and Emotional Function (LSMD, 12.15; 95% CI, 7.22; 17.09)..."

P3 data • Migraine

Efficacy and safety of mAbs anti-CGRP/CGRP R (eptinezumab and erenumab) or atogepant in combination with onabotulinumtoxinA in refractory chronic migraine: a clinical trial protocol. (PubMed, Pain Manag) - "Chronic migraine is a disabling neurovascular disorder that represents the leading cause of years lived with disability in people under 50 with a remarkable social burden due to widespread resistance to the front-line treatments used routinely in current clinical practice. Furthermore, a feasible salivary biomarker of migraine is under investigation in the prospective stage of the study. Based on recent expert opinions supporting the switch to easy-to-use small molecule calcitonin gene-related peptide (CGRP)-targeting, i.e. rimegepant or atogepant in unresponsive patients, the present study may offer to clinicians a novel treatment to enhance the therapeutic preventive machinery in chronic migraine."

Journal • CNS Disorders • Migraine • Pain

Aquipta hailed as game-changer in migraine prevention at AbbVie symposium (Korea Biomedical Review) - P3 | N=NA | "The symposium, organized by AbbVie Korea to share the latest advances in migraine prophylaxis and foster academic exchange among experts, was attended by more than 100 neurologists both online and offline....In particular, a post-hoc analysis of the phase 3 study evaluating the efficacy and safety of Aquipta in preventing migraine showed that the Aquipta 60 mg once-daily treatment group showed rapid improvement in AIM-D (physical activity and performance of functioning) as early as one week of treatment compared to the placebo group. This improvement was sustained for up to two to four weeks."

P3 data • Migraine

Aquipta hailed as game-changer in migraine prevention at AbbVie symposium (Korea Biomedical Review) - "Expectations are higher than ever for Aquipta (atogepant), an oral CGRP treatment that is effective in preventing migraine and easy to take...This was evident at 'AbbVie's Migraine Portfolio: from CM to EM Symposium,' held at the Grand InterContinental Seoul Parnas on March 6...Lee shared interim results from the CAPTURE study, a Patient-Reported Outcome (PRO) study of migraine...The study showed that as migraine frequency increases, the impact on quality of life, as well as loss of productivity and disability in daily activities, is greater...Moon Heui-soo, a professor of neurology at Kangbuk Samsung Hospital....spoke on highlighting the changes that the launch of Aquipta, an oral CGRP therapy, has brought to the migraine prevention treatment landscape."

Patient reported outcomes • Real-world • Migraine

ATOM: Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation

New trial • CNS Disorders • Migraine • Pain

AbbVie Files Migraine Med Atogepant in Japan (Pharma Japan) - "AbbVie said on March 14 that it has submitted a new drug application in Japan seeking regulatory approval for atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of migraines in adults....The filing this time is based on the results of Japan PII/III studies covering adult patients with chronic and recurrent migraines as well as a global PIII trial including Japanese. The once-daily agent, known with the brand names of Qulipta and Aquipta, has already been approved in some 50 countries."

Japan filing • Migraine

Release: Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine (clinicaltrials.gov) - P3 | N=523 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

Network Meta-Analysis Comparing Efficacy and Safety Outcomes of Atogepant, Rimegepant, and Galcanezumab in Patients with Episodic Migraine After Including CHALLENGE-MIG Trial (AAN 2025) - "Objective:Network meta-analysis (NMA) of atogepant (Ato) relative to rimegepant (Rime) and galcanezumab (Galc) after inclusion of the CHALLENGE-MIG trial for efficacy and safety outcomes in episodic migraine (EM) patients.Background:The NMA included 5 randomized, controlled trials for the preventive treatment of EM (ADVANCE [Ato 60 mg], BHV3000-305 [Rime 75 mg], EVOLVE-1, EVOLVE-2 [Galc 120 mg], and CHALLENGE-MIG [Rime 75 mg, Galc 120 mg]).Design/A fixed-effects model was chosen to compare the efficacy and safety of Ato versus Rime, Galc based on model fit statistics. Ato 60 mg demonstrated significant improvements in 3 of the 4 efficacy outcomes compared to Rime 75 mg and significantly increased odds of achieving ≥50% RR in MMD relative to Galc 120 mg. Other efficacy outcomes were not significantly different. Ato 60 mg demonstrated comparable all-cause d/c and TEAEs relative to Rime and Galc."

Retrospective data • CNS Disorders • Migraine • Pain

The Safety and Effectiveness of Dual Calcitonin Gene-Related Peptide (CGRP) Therapies for Migraine Treatment: A Focus on Small Molecule Antagonist and Ligand Monoclonal Combinations (AAN 2025) - "Our study aims to assess the effects of this dual-CGRP approach.Design/A retrospective matched cohort study was conducted at a neurological care center in Hawaii, analyzing 90 chronic migraine patients aged ≥18 years treated with CGRP inhibitors (L-mAbs: fremanezumab, galcanezumab, eptinezumab; SMAs: ubrogepant, rimegepant, atogepant; or a combination)...Variables included age, age at diagnosis, sex, onabotulinumtoxinA use, headache frequency, duration, severity, and associated symptoms before and three months post-treatment...Dual-CGRP regimens may provide improved effectiveness for controlling migraine symptoms by significantly reducing headache severity and aura symptoms without significant adverse events."

Clinical • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Impact of Atogepant on Activity Limitation in Participants With Episodic Migraine and Chronic Migraine: Post Hoc Analyses of ADVANCE, ELEVATE, and PROGRESS (AAN 2025) - "As early as week 1, after initiating Ato, a higher proportion of participants reported they could do everything compared with Pbo treated participants. The results were consistent at Weeks 2, 3, 4 across the three phase 3 trials and suggest the rapid onset of improved function in Ato treated participants."

Retrospective data • CNS Disorders • Migraine • Pain

Exploratory Efficacy Results from the TANDEM Trial: Safety, Tolerability, and Efficacy of Ubrogepant for the Acute Treatment of Migraine in Participants Taking Atogepant for the Preventive Treatment of Episodic Migraine (AAN 2025) - "Ubrogepant-treated participants recalled high rates of pain freedom and relief,and high treatment optimization when used concomitantly with atogepant 60mg QD.No new safety signals were identified."

Clinical • CNS Disorders • Migraine • Pain

Milk and Plasma Pharmacokinetics of Single-Dose Atogepant in Healthy Lactating Women (AAN 2025) - "Atogepant average milk:plasma concentration ratio was 0.076 following a 60mg dose in lactating women. Based on lack of atogepant accumulation upon daily dosing, the low cumulative amount of atogepant excreted in breast milk and the low RID of 0.188%, atogepant may be considered, for the preventive treatment of migraine in lactating women."

Clinical • PK/PD data • CNS Disorders • Dyspepsia • Hematological Disorders • Migraine • Pain

Impact of Atogepant on the Improvement in the Severity of Overall Migraine Symptoms Using PGI-S: Post hoc Analyses from ADVANCE, ELEVATE, and PROGRESS (AAN 2025) - "A higher proportion of participants achieved no/mild migraine symptoms, as assessed by PGI-S, with Ato treatment compared with Pbo starting at Week 4. A higher proportion of Ato-treatment participants had no/mild migraine symptoms across three timepoints in the three phase 3 trials."

Retrospective data • CNS Disorders • Migraine • Pain

Impact of Atogepant on Migraine Headache Severity for the Preventive Treatment of Episodic Migraine: A Post-Hoc Analysis of the 12-Week ADVANCE and 52-Week Open-Label Trials (AAN 2025) - "Atogepant reduced the number of monthly moderate/severe migraine headache days and mean pain severity of migraine headache days compared with placebo in ADVANCE, and reductions were consistent across 52 weeks in the open-label trial."

Clinical • Retrospective data • CNS Disorders • Migraine • Pain

Sex Differences in Treatment Response and Patient Preference in Gepant Users: A Real-World Survey Study from a Tertiary Headache Center (AAN 2025) - "Gepant acute (rimegepant vs ubrogepant) and preventive (rimegepant vs atogepant) responses appear similar between sexes according to this real-world survey at a tertiary headache center. Further research is needed to understand the sex-based differences in gepant use response."

Clinical • Real-world • Real-world evidence • Pain

Impact of Atogepant on Daily Functioning in Patients with Episodic Migraine and Chronic Migraine: Activity Impairment in Migraine-Diary (AIM-D) Item-Level Analysis (AAN 2025) - "As early as Week 1, a higher percent change from baseline in all AIM-D items was observed among Ato-treated participants compared with Pbo, demonstrating early improvements in function."

Clinical • CNS Disorders • Migraine • Pain

Comparative Efficacy and Safety of Atogepant as Prophylaxis for Chronic and Episodic Migraine in Adults: a Systematic Review with Meta-Analysis and Trial Sequential Analysis (AAN 2025) - "This meta-analysis indicates that atogepant effectively reduces migraine frequency and acute medication use while improving quality of life. Despite reports of adverse effects like constipation and nausea, the benefits outweigh the risks. Long-term safety trials and studies on chronic migraine are needed to validate these findings."

Retrospective data • Review • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Economic Impact of Early Vs. Late Initiation of Atogepant for The Preventive Treatment of Migraine (AAN 2025) - "Reducing 2-step edits / 1-step edit to 0-step edits for atogepant demonstrated annual cost savings of more than $1,000 per patient for US payors. These model-based estimates should be assessed in randomized trials of benefit designs."

HEOR • CNS Disorders • Migraine • Pain

Impact of Atogepant on Functional Outcomes in Trial Completers for the Preventive Treatment of Episodic Migraine: A Post-Hoc Analysis of the ADVANCE Trial (AAN 2025) - "Completers who received Ato 60 mg QD demonstrated greater improvements in functional outcomes relative to Pbo at all time points."

Retrospective data • CNS Disorders • Migraine • Pain

Migraine: Aquipta as a new prophylactic agent [Google translation] (Apotheke Adhoc) - "As of March 1, a new prophylactic medication will be available for adults who suffer from migraines on at least four days per month...The active ingredient atogepant will be available in Germany from March 1st. With Aquipta from Abbvie, the first oral CGRP receptor antagonist for migraine prophylaxis is now available for patients suffering from episodic and chronic migraines....Aquipta is available in 10 mg and 60 mg tablet strengths. The recommended dose is 60 mg once daily. The tablets can be taken with or without food."

Launch Europe • Migraine