News

Strong support for early use of anti-CGRP mAbs including results from the largest real world mAb study and economic analyses, and latest gepant data for migraine prevention and acute treatment, were among 2024’s clinical research highlights for Professor Koen Paemeleire, from Ghent University Hospital, Belgium. “We’ve seen a huge wave of publications on the CGRP …

In the Phase 3 Sunrise trial carried out in a predominantly Asian population with chronic migraine, eptinezumab has been shown to significantly reduce monthly migraine days (MMDs). Over weeks 1 through 12, mean reductions in MMDs from baseline were -7.5 with eptinezumab 300 mg and -7.2 with eptinezumab 100 mg compared to -4.8 days with …

Migraine deterioration during an erenumab treatment holiday is reversible, according to data from the APOLLON long-term, flexible dosing, safety and tolerability study during which patients were able to interrupt treatment once for a drug holiday of up to 24 weeks.1 In the study, 108/701 (15.4%) patients with episodic or chronic migraine who had successfully completed …

Top-line data from the Phase 3 SPACE trial support the efficacy and safety of fremanezumab for the prevention of episodic migraine in children and adolescents. The trial met its primary endpoint, with fremanezumab showing a statistically significantly greater reduction in monthly migraine days over 12 weeks compared with placebo. Safety data were consistent with those …

New research has shown that CGRP signalling primes interactions between meningeal lymphatic vessels (MLVs) and immune cells, supporting a previously unrecognised role for the lymphatic system in chronic migraine. “Our study has highlighted the importance of the brain’s lymphatic system in the pathophysiology of migraine pain,” said Professor Kathleen M. Caron, UNC School of Medicine, Chapel …

CGRP inhibition is associated with decreased rates of acne and rosacea compared with no inhibition or indirect inhibition in patients experiencing migraine. This is the finding from a cohort study using data from the TriNetX US Collaborative Network of 62 healthcare organisations carried out in May 2024.1 Using 1-year Cox proportional hazards models with 95% …

Atogepant is effective in preventing chronic migraine (CM), with and without acute medication overuse, according to results of a subgroup analysis of the PROGRESS trial. Of 755 study participants in the modified intent-to-treat population, 500 (66.2%) met criteria for acute medication overuse at baseline. The least squares mean difference (LSMD) (95% CI) from placebo in …

New data from the largest real world study of CGRP mAbs in patients with high-frequency episodic or chronic migraine (CM) have shown that more frequent and disabling migraines reduce the likelihood of a good response – underlining the importance of earlier treatment.1 In the European multicentre, prospective study, 5818 patients with a median 20 monthly …

Over 70% of patients with episodic migraine who respond initially to atogepant treatment achieve a sustained response with continued treatment, according to post hoc analyses of results from the ADVANCE trial and a separate open label long term safety study (LTS).1 The findings are comparable with recently reported long term data from the PROGRESS and …

Aquipta (atogepant) can be prescribed for migraine prevention free of charge on the National Health Service (NHS) in England, following a recommendation by the National Institute for Health and Care Excellence (NICE). Adults who have at least four migraine days per month and have previously failed on at least three preventive medicines are eligible for treatment. Physicians …

Erenumab may have potential for relieving the facial redness and flushing of rosacea, according to results of a small, open label study of 30 individuals with the condition. Study participants received monthly erenumab 140 mg sc for 12 weeks at the Danish Headache Center, Copenhagen, Denmark.  Mean days of moderate to extreme flushing were reduced …

The American Headache Society (AHS) has recommended that anti-CGRP therapies should be considered as first line treatment for migraine prevention.1 In a new consensus statement based on a comprehensive review of clinical trial and real-world experience, the AHS concluded that the evidence supporting the efficacy, tolerability, and safety of CGRP-targeting therapies for migraine prevention is …

A decrease in neural activity in distinct regions of the brain following erenumab 70 mg has been reported in a placebo-controlled, double-blind, randomised study of 40 patients with migraine who underwent fMRI scanning. This change was seen mainly in individuals who showed a clinical benefit from the anti-CGRP treatment. Seven out of 21 patients in …

Gepants have additional effects on CGRP-induced vasorelaxation when used with erenumab, supporting their efficacy in treating migraine attacks in patients already using erenumab as prophylaxis. These are the findings of a study investigating the effects of combination treatment in human coronary artery (HCA) and human middle meningeal artery (HMMA) segments. pA2 or pKb values were calculated to …

CGRP mAbs reduce migraine aura days as well as migraine headache days, according to data from a pilot prospective observational cohort study of 14 patients with migraine aura treated with erenumab, fremanezumab or galcanezumab and followed up for 12 months. Mean monthly aura days were reduced from a median of 13 at baseline (interquartile range: …

Full results of the PRODROME trial, published last week in The Lancet, confirm that ubrogepant 100 mg taken during the prodromal phase of migraine can prevent the onset of moderate or severe headache within 24 hours and 48 hours after administration, and reduce functional disability and development of headache of any intensity within 24 hours …

The European Commission has approved Aquipta (atogepant) for migraine prophylaxis in adults who have four or more migraine days per month. The decision makes atogepant the first once-daily oral CGRP receptor antagonist (gepant) for prevention of chronic and episodic migraine in the EU. The approval is supported by data from the Phase 3  PROGRESS and …

Results of the Phase 3 PROGRESS trial demonstrating the efficacy and safety of atogepant in the treatment of chronic migraine (CM) have been published in the Lancet.1 In the study of 778 patients in 16 countries, baseline mean monthly migraine days (MMD) were 18.6 (SE 5.1), with atogepant 30 mg twice a day, 19.2 (5.3) …

Top-line data from the head-to-head CHALLENGE-MIG study of galcanezumab and rimegepant in episodic migraine in adults have shown that galcanezumab did not achieve statistical superiority. In the three month, double blind study, 580 patients were randomised to either four injections of galcanezumab 120 mg (a loading dose of two injections followed by two additional monthly …

The National Institute for Health and Care Excellence (NICE) has recommended that  Vydura (rimegepant) can be prescribed for prevention of episodic migraine in adults, free of charge on the National Health Service (NHS) in England. The new NICE guidance, which is expected to be published in its final form in July 2023, states that rimegepant …

Vydura (rimegepant) has been approved by the Scottish Medicines Consortium for restricted use on the National Health Service (NHS) for acute treatment of migraine with or without aura.1 Doctors in Scotland will be able to prescribe rimegepant free to patients who have had inadequate symptom relief after trials of at least two triptans or in …

The US Food and Drug Administration (FDA) has approved an expanded indication for Qulipta (atogepant) 60 mg for the preventive treatment of chronic migraine in adults. The drug is the first oral CGRP receptor antagonist to be approved for prevention of both episodic and chronic migraine. “The FDA approval is an important milestone, providing those …

In a network meta-analysis of data from seven studies with nearly 13,000 patients with migraine, the 5-HT1F receptor agonist, lasmiditan, had a greater effect on two-hour pain freedom compared to placebo, than was  seen with rimegepant and ubrogepant. However, lasmiditan was linked to significantly greater odds of adverse events, such as dizziness, nausea and somnolence. …

New data support a role for trigeminal activation in the pathophysiology of headache in patients with COVID-19.1 CGRP levels were 30% higher in hospitalised COVID-19 patients with acute headache than in a similar group of infected individuals without headache. In both groups, CGRP levels were higher than in healthy controls. In 25 inpatients with COVID-19 …

Zavzpret (zavegepant) nasal spray has been approved by the US Food and Drug Administration for the acute treatment of migraine with or without aura in adults, making it the first approved intranasal formulation of an anti-CGRP therapy. The FDA approval is supported by research including a Phase 3 clinical trial, published in Lancet Neurology, in …

Hormone dependent changes in CGRP concentration have been identified in women with episodic migraine using tear fluid.  In a study of 180 women, those with migraine and a regular menstrual cycle had significantly higher CGRP concentrations in tear and plasma fluid during menstruation compared to participants without migraine (tear fluid: 1.20 ng/ml vs. 0.4 ng/ml, …

The National Institute for Health and Care Excellence (NICE) has not recommended that rimegepant should be available for acute or preventive treatment of migraine on the National Health Service (NHS) in England. In its appraisal consultation document, NICE concluded that evidence to support the proposed use of rimegepant for acute treatment after two or more …

The presence/absence of non-ictal cephalic allodynia has been used to identify galcanezumab responders with nearly 80% accuracy and galcanezumab non-responders with nearly 85% accuracy. Using quantitative sensory testing (QST) with strict criteria for allodynia (heat 32-40°C, cold 32-20°C, mechanical <60 g), researchers have reported a 21% incidence of pre-treatment non-ictal cephalic allodynia in 24 responders …

Emerging evidence is linking CGRP mAbs to alopecia in some patients. Two case reports and a review of data from the Food and Drug Administration Adverse Event Reporting System (FAERS) add to previous post marketing findings with erenumab that led to alopecia being included in the drug’s US label in May 2021.1,2 In the case …

Phase 3 data on the intranasal CGRP receptor antagonist, zavegepant, published in Lancet Neurology, support its efficacy, safety and tolerability in the acute treatment of migraine in adults with two to eight moderate or severe migraine attacks per month (NCT04571060).1 Two hours after a 10 mg dose of zavegepant nasal spray, 147/623 (24%) patients were …

The National Institute for Health and Care Excellence (NICE) has recommended that patients with migraine in England can be prescribed Vyepti (eptinezumab) for migraine prevention free of charge on the National Health Service (NHS) in England.1 This means that all four CGRP mAbs can now be prescribed on the NHS in England. The new NICE guidance, …

Qulipta (atogepant) has been approved by Health Canada for the prevention of episodic migraine (< 15 migraine days per month) in adults, making Canada the second country in which the drug has been approved. “Migraine is one of the leading causes of disability in Canada and impacts a person’s ability to function and perform their …

Salivary CGRP may predict response to anti-CGRP therapies, and patients with episodic migraine, less frequent migraine and a good response to triptans are more likely to be super-responders to CGRP mAbs.1.2 These were the conclusions from two studies investigating opportunities for precision medicine for migraine that were presented at the conference. In a further reported …

Erenumab is not associated with systematic wearing-off, according to a post hoc analysis of data from four pivotal randomised controlled trials in a total of 2338 patients with episodic or chronic migraine.1-5 In the full study population, mean change in weekly migraine days at week 4 compared with the average over week 1-3 ranged from 0.15 …

Erenumab did not reduce pain intensity compared with placebo in patients with trigeminal neuralgia (TN), and CGRP probably does not have an important role in paroxysmal pain, conclude Danish Headache Center researchers in a recent paper in Lancet Neurology.1 In a randomised, double-blind, placebo-controlled trial of erenumab 140 mg in 80 patients with idiopathic or …

Growing evidence of the efficacy and tolerability of combined CGRP mAb and gepant treatment is emerging from clinical practice. Results of a retrospective chart review of 55 adult patients carried out at a New York practice showed that adding fremanezumab to gepant therapy reduced average monthly migraine days (MMDs) by -6.5 days (standard deviation [SD] …

Vydura (rimegepant) has received EU marketing authorisation in the acute treatment of migraine with or without aura, and for the prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. Vydura orally disintegrating tablet is the first medicine approved for both acute and prophylactic treatment of migraine in the EU. “Vydura’s …

Qulipta (atogepant) significantly reduced mean monthly migraine days (MMDs) compared to placebo in adult patients with chronic migraine (CM), according to data announced from the Phase 3 PROGRESS trial. The results will support a submission to expand the use of atogepant to include preventive treatment of CM in the USA. The drug was approved for …

Rimegepant 75 mg orally dissolving tablet is likely to get the go ahead for EU approval, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which advises the European Medicines Agency (EMA) on product approvals. Following a CHMP opinion, an approval decision is generally made within 10 weeks. The positive …

Top-line data from a Phase 3 rimegepant trial for the acute treatment of migraine in 1,431 adult patients in China and South Korea have shown that the study met its co-primary endpoints. Two hours after a single dose of rimegepant 75 mg orally dissolving tablet, significant improvements were seen compared to placebo in freedom from …

Vyepti (eptinezumab) has received approval by the European Medicines Agency for migraine prevention in EU countries and will be the first intravenous CGRP monoclonal antibody (mAb) treatment available in Europe. Like other CGRP mAbs, eptinezumab has been approved for prophylactic treatment of migraine in adults who have at least four migraine days per month. The …

Top-line Phase 3 data on the investigational, intranasal agent, zavegepant, as acute treatment of migraine have demonstrated significantly greater improvement in pain freedom and most bothersome symptom than placebo. The study achieved its co-primary regulatory endpoints of pain freedom (zavegepant 24% vs placebo 15%, p<0.0001) and freedom from most bothersome symptom (zavegepant 40% vs placebo …

Patients with episodic migraine are being enrolled in CHALLENGE-MIG – a Phase 4, head-to-head study of the CGRP mAb injection, galcanezumab, and the oral gepant, rimegepant. The primary endpoint is the percentage of patients with ≥50% reduction from baseline in monthly migraine headache days. Secondary endpoints include quality of life and migraine disability improvements and …

Full data from the HER-MES trial showing that significantly fewer patients with episodic or chronic migraine discontinued erenumab 70 or 140 mg/month than topiramate 50-100 mg/day, and more patients achieved > 50% reduction in monthly migraine days (MMDs), have been published in Cephalgia. In the Phase 4, 24-week study which enrolled 777 adult patients, 10.6% …

The US Food and Drug Administration (FDA) has approved the oral CGRP receptor antagonist, Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. The drug will be available as once-daily treatment in three doses – 10 mg, 30 mg and 60 mg. The approval is supported by data evaluating the efficacy, safety and …

The ADVANCE study showing that atogepant significantly reduced mean monthly migraine days (MMDs) over 12 weeks has been published in the New England Journal of Medicine. In the efficacy analysis of 873 patients, MMDs were reduced from a baseline of 7.5-7.9 days by 3.7 days with atogepant 10 mg, 3.9 days with atogepant 30 mg …

Ajovy (fremanezumab) and Emgality (galcanezumab) have been approved for inclusion on the Pharmaceutical Benefits Scheme (PBS) in Australia for prescription to patients with chronic migraine. This means that the cost of treatment will be subsidised by the Australian government. Patients will need to fulfil three criteria to benefit from reduced pricing: A diagnosis of chronic …

European migraine specialists have urged head-to-head studies of preventive therapies, including CGRP monoclonal antibodies (mAbs), topiramate and botulinum toxin A. This follows two recent systematic reviews with meta-analyses showing that all three treatments have superior efficacy to placebo but topiramate has a less favourable safety profile and higher drop out rate compared to the other …

Galcanezumab significantly reduces mean weekly total pain burden in patients with episodic cluster headache, according to results of a post hoc analysis of the Phase 3 study which supported US approval of galcanezumab in the indication. The new analysis, aimed at addressing the multiple pain dimensions that may contribute to the total burden of episodic …

Clinicians are being encouraged to report experiences of switching patients between CGRP mAbs in order to better understand potential benefits and inform treatment access policies of payers and care providers. A report of seven patients with chronic migraine and prior treatment with three to 14 preventive drugs (mean 9.5) has demonstrated the impact of switching …