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Imaging data support central effects of erenumab

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 …

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Additive effects of multiple anti-CGRP therapies seen on CGRP-induced vasorelaxation

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 …

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CGRP mAbs reduce migraine aura days

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: …

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PRODROME results published in The Lancet

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 …

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Aquipta (atogepant) receives EU approval for migraine prevention

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 …

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PROGRESS results for atogepant in chronic migraine published

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) …

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CHALLENGE-MIG study shows similar response rates for galcanezumab and rimegepant

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 …

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NICE recommends Vydura (rimegepant) for episodic migraine prevention

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.1 The new NICE guidance, which is expected to be published in its final form in July 2023, states that rimegepant …

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Vydura (rimegepant) makes progress in UK health technology assessments

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 …

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Qulipta (atogepant) indication expands to chronic migraine in USA

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 …

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Meta analysis highlights comparative benefits of acute migraine therapies

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. …

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CGRP levels rise in COVID-19 headache

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 …

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Zavzpret (zavegepant) nasal spray receives migraine approval in USA

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 …

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CGRP levels in tear fluid offer new clues to migraine in women

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, …

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NICE draft guidance rejects rimegepant for NHS use in England

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 …

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Non-ictal cephalic allodynia predicts CGRP mAb response in patients with migraine

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 …

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Hair loss attributed to CGRP mAbs

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 …

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Phase 3 zavegepant data published in Lancet Neurology

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 …

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NICE recommends Vyepti (eptinezumab) for migraine prevention

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, …

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Qulipta (atogepant) approved for migraine prevention in Canada

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 …

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Predicting response to anti-CGRP therapies

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 …

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Post hoc analysis shows no systematic wearing-off effects with erenumab

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 …

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Erenumab disappoints in trigeminal neuralgia

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 …

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Support for combination anti-CGRP therapies

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] …

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EU approval for Vydura (rimegepant) in acute and preventive migraine treatment

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 …

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Qulipta (atogepant) study meets primary endpoint in chronic migraine

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 …

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Rimegepant en route to EU approval

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 …

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Rimegepant efficacy confirmed in Asia-Pacific study

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 …

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Vyepti (eptinezumab) approved for migraine prevention in Europe

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 …

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Phase 3 zavegepant trial demonstrates acute pain relief in migraine

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 …

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Galcanezumab and rimegepant go head-to-head in CHALLENGE-MIG study

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 …

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HER-MES data support superiority of erenumab over topiramate in migraine prevention

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% …

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Qulipta (atogepant) approved for episodic migraine in USA

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 …

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ADVANCE trial of atogepant published in New England Journal of Medicine

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 …

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Ajovy and Emgality granted PBS status in Australia

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 …

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Migraine experts urge head-to-head prevention studies

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 …

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Post hoc analysis sheds further light on galcanezumab in episodic cluster headache

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 …

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Clinicians urged to report experience of switching patients between CGRP mAbs

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 …

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Restless legs syndrome reported with CGRP mAbs

Two cases of restless legs syndrome (RLS) have been described in patients with chronic refractory migraine using CGRP mAbs, although the authors of the report stress that caution is needed before establishing a causal relationship. The affected patients developed typical RLS symptoms 1.5 and four months after starting erenumab 140 mg, respectively. In the first …

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Patterns of CGRP release identified during menstrual cycle

CGRP levels have been shown to change significantly during the menstrual cycle, with variations in patterns identified in women with migraine and/or endometriosis. In a study of 124 women, the change in plasma CGRP levels between menstruation and the periovulatory period was different between groups (p = 0.007). Women with migraine alone had a decrease …

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Nurtec (rimegepant) becomes first migraine therapy for acute and preventive treatment

The US Food and Drug Administration (FDA) has approved Nurtec ODT (rimegepant), in a dose of 75mg every other day, for the preventive treatment of episodic migraine in adults. This follows the drug’s US approval in February 2020 for the acute treatment of migraine with or without aura in adults. “The FDA approval of Nurtec …

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Additive benefits of anti-CGRP therapy and botulinum toxin in chronic migraine

Adding CGRP monoclonal antibodies (MAbs) to onabotulinumtoxinA treatment reduced monthly headache days (MHDs), improved migraine-related disability scores and was well tolerated with no new safety signals. These were the conclusions from a retrospective chart review of 300 patients with chronic migraine treated at a single US clinic site with > 2 consecutive cycles of onabotulinumtoxinA …

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Safety of anti-CGRP therapy during COVID-19 pandemic

Using anti-CGRP monoclonal antibodies (MAbs) does not increase the risk of COVID-19, or worsen prognosis in those who get the infection, according to recently published data from the Spanish CGRP-COVID Study Group. Of 300 patients with migraine recruited through a Spanish Society of Neurology survey, 51.7% (155/300) were treated with anti-CGRP monoclonal MAbs. Of the …

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Retrospective analysis supports erenumab in trigeminal neuralgia

Improved pain scores and mood have been reported by patients with trigeminal neuralgia (TN) who were treated with erenumab. Nine out of 10 patients diagnosed with TN and treated with erenumab for six months reported improvement in pain severity according to a numeric pain rating scale (NPRS) from 0 to 10, and in global mood. …

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Long term data support eptinezumab safety and improved quality of life for patients

Two-year data for eptinezumab 300 mg i.v. demonstrate a favourable safety profile, limited long-term immunogenicity, early and sustained reductions in migraine-related burden, and improvements in health-related quality of life, conclude the authors of the newly published PREVAIL study. Results were reported from the Phase 3 open label study of 128 adults with chronic migraine who …

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Aimovig (erenumab) available on NHS in England and Wales

The National Institute for Health and Care Excellence (NICE) has confirmed that erenumab can be prescribed for migraine prevention free of charge on the National Health Service (NHS) in England and Wales. Physicians may consider erenumab 140 mg as an option for migraine prevention in adults who have four or more migraine days a month …

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Discovery of CGRP role in migraine recognised in Brain Prize 2021

CGRP Forum Editor, Peter Goadsby, and Editorial Board Member, Lars Edvinsson, are two of the four recipients of the prestigious Brain Prize 2021 for their pioneering work on CGRP as a cause of migraine. The award, made annually by the Lundbeck Foundation, honours scientists who have made outstanding contributions to the field of neuroscience. “It …

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New insights on structure and dynamics of CGRP receptor

Cryo-electron microscopy (cryo-EM) research has shed new light on the binding and activation mechanism of the CGRP receptor, contributing to greater understanding of the progression of the molecular events that lead to migraine. The research, led by researchers at Monash University, Melbourne, Australia, and published in Science, show how the binding of CGRP to the …

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COVID-19 vaccination: no need to reschedule anti-CGRP treatment

Patients using CGRP monoclonal antibodies (MAbs) do not need to delay treatment when they are scheduled to have COVID-19 vaccination as there is no evidence that COVID-19 vaccines affect CGRP MAb efficacy or that CGRP MAbs affect vaccine efficacy. These are the conclusions of a recent editorial in Headache1 which also says that there is …

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Five-year efficacy and safety data for erenumab published

Five-year data on the efficacy and safety of erenumab in the prevention of episodic migraine have been published in the European Journal of Neurology.1 In the five-year, open-label extension of a 12-week, double-blind, placebo-controlled trial, 250/383 (65.3%) patients switched from erenumab 70 mg to erenumab 140 mg, and 215 (56.1%) completed treatment. Mean reduction in …

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