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Emgality (galcanezumab) receives EU approval in migraine prevention

Emgality (galcanezumab) has become the second anti-CGRP agent to be approved in the EU for the prevention of migraine in adults experiencing at least four migraine days per month. Aimovig (erenumab) received EU approval for the same indication in July 2018. The EU approval for galcanezumab follows that in the US in September 2018. The drug …

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Early response to fremanezumab in high-frequency episodic migraine

Fremanezumab treatment provides rapid migraine prevention and reduces the need for acute medication in patients with high-frequency episodic migraine (HFEM), according to results of a multicentre, double-blind, placebo-controlled phase 2 study (NCT02025556). Compared to placebo, decreases in migraine days were seen during the first week of therapy with fremanezumab 225 mg and 675 mg, with …

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No link found between medication-overuse headache and CGRP

Patients with medication-overuse headache (MOH) have been shown to have normal serum levels of CGRP and nociceptin, in contrast to previous studies in patients with migraine which showed raised levels of CGRP and low levels of nociceptin. Serum levels of the two peptides were compared in 17 patients with MOH (71% of whom had chronic …

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Meta analysis of anti-CGRP therapy underlines efficacy and safety

CGRP monoclonal antibody therapy significantly reduces monthly migraine days and migraine-specific medication consumption from baseline (weighted mean difference [WMD] = - 1.52; 95%CI - 1.92 to - 1.11, p < 0.001; and - 1.45; 95%CI, - 2.17 to - 0.72, p< 0.001 respectively). Treatment also significantly increases the ≥ 50% reduction from baseline in migraine days per month (RR = 1.54; 95%CI, 1.38 to1.71, p < 0.001). These were the key findings …

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Is CGRP a novel target for cardiovascular treatment?

Growing interest in the highly potent vasoactive peptide, CGRP, as a novel treatment for cardiovascular disease is addressed in a recent review of CGRP research in hypertension, ischaemia and heart failure. Evidence discussed by the review authors includes: Rodent studies in which CGRP was shown to play a protective role in the onset and progression …

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Cryo-EM sheds new light on CGRP receptor function

Cryo-electron microscopy has been used to explore the structure of the active human CGRP receptor in complex with CGRP and the Gs-protein heterotrimer, and to provide new insights into the control of G-protein-coupled receptor function. The CGRP receptor is a heterodimer of calcitonin receptor-like receptor (CLR) and receptor activity-modifying protein 1 (RAMP1). CLR is a class B G-protein-coupled receptor and …

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Pivotal studies published for erenumab and galcanezumab

Efficacy and tolerability data from the Liberty study of erenumab in patients who had previously failed two-to four preventive therapies, and 100% response data for galcanezumab in the EVOLVE-1 and EVOLVE-2 studies have been published.1,2 In the Liberty analysis, 30% of patients with episodic migraine who used erenumab 140 mg every four weeks had a …

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Should children and adolescents with migraine have anti-CGRP therapy?

Children and adolescents may be considered for anti-CGRP therapy in appropriate cases, with close follow-up and attention to patients’ age, pubertal state, medical comorbidities and other characteristics. These are the conclusions of members of the Pediatric and Adolescent Headache special interest group of the American Headache Society (AHS), in the current absence of clinical trial …

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Emgality (galcanezumab) approved for migraine prevention in USA

Emgality (galcanezumab) 120 mg injection has been approved by the US Food and Drug Administration (FDA) for the preventive treatment of migraine in adults. The drug is available as a once-monthly, self-administered, subcutaneous injection. The recommended dose is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by …

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Ajovy (fremanezumab) wins US approval in migraine prevention

Ajovy (fremanezumab) has become the second anti-CGRP agent to gain approval for migraine prophylaxis in adults in the USA. It is the first and only anti-CGRP treatment with both monthly (225 mg) and quarterly (675 mg) dosing options. “About 40% of people living with migraine may be appropriate candidates for preventive treatment, yet the majority …

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Artery studies confirm fremanezumab antagonism on CGRP vasodilatory effects

Fremanezumab competes with CGRP to a similar extent in human cerebral, middle meningeal and abdominal arteries, according to in vitro studies aimed at extending understanding of the vascular effects of CGRP blocking agents. In precontracted arteries, CGRP administration caused concentration-dependent relaxation of 80% in intracranial arteries and 100% in abdominal arteries, which was markedly reduced …

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Phase 2b patient-reported outcomes data published on galcanezumab

Significant functional improvements have been reported after 12 weeks treatment with galcanezumab in a post-hoc analysis of a Phase 2b study in patients with episodic migraine (NCT02163993). Results of migraine-specific quality of life questionnaire (MSQ) covariance analysis showed significant differences in least square mean changes from baseline between galcanezumab and placebo for all domains. Total …

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Climb every mountain – even if you get migraine

Climbers who get migraines or any type of headache at low altitude are only slightly more likely to get acute mountain sickness (AMS) at altitude than other climbers. A multivariate analysis using data from 1320 mountaineers staying overnight at the Capanna Margherita (4559 m) in Italy has shown that migraine or headache history is a minor …

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Preschool abdominal migraine is best predictor of migraine at primary school age

Children under five who get abdominal migraine have a probability of getting migraine during their primary school years of over 50%, according to findings from a retrospective cohort study of 55,035 children born in 2006 with no diagnosis of migraine up to the age of five years. In contrast, other episodic syndromes experienced by under-fives are poor …

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Look out for multimorbidity in patients with chronic migraine and medication overuse headache

Recognising multimorbidity in patients with chronic migraine (CM) and medication overuse headache (MOH) is important for improving the management of these complex patients, conclude the authors of a study aimed at addressing the rate and impact of multimorbidity in this group. In the study of 194 patients with CM undergoing structured withdrawal for coexisting MOH, 61% …

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EMA reinforces actions to prevent valproate use for migraine prevention in pregnancy

Newly published guidance from the European Medicines Agency (EMA), in conjunction with the European Headache Federation, calls for more extensive restrictions on valproate prescribing to women with migraine, better public awareness, and a more effective education campaign to reduce the risk of in utero exposure. The EMA has taken this action in response to evidence …

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Aimovig (erenumab) receives EU approval for migraine prevention

Aimovig (erenumab) has received EU approval for the prevention of migraine in adults experiencing four or more migraine days per month. This follows recent approvals in the US, Switzerland and Australia. Aimovig remains the first and only approved treatment designed to block the CGRP receptor and can be self-administered every four weeks using the SureClick® …

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CGRP infusion provokes cluster headache

CGRP infusion has been shown to provoke cluster headache attacks in active-phase episodic cluster headache and in chronic cluster headache, but not in remission-phase episodic headache. Results of a double-blind, placebo-controlled, 2-way crossover study published online in JAMA Neurology showed that, in the active phase, CGRP induced cluster headache attacks in 8/9 patients (mean, 89%; 95% …

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Phase 3 EVOLVE-2 study of galcanezumab published in Cephalgia

Published data from the six-month, Phase 3 EVOLVE-2 study (NCT02614196) have confirmed that monthly treatment with galcanezumab 120 mg and 240 mg reduced mean monthly migraine headache days by 4.3 and 4.2 days, respectively, compared to 2.3 days with placebo. Both doses were superior to placebo for all key secondary endpoints and injection site pain was the …

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Recurrent headache + asthma + allergic rhinitis may = migraine in adolescents

Clinicians should be on the look-out for adolescents presenting with recurrent headache who also have asthma and allergic rhinitis as the combination is highly suggestive of migraine, advise Israeli researchers following a large-scale analysis of 17-year olds. Of 113,671 adolescents in an electronic database of 17-year-old draftees between 1987-2010, 4% were diagnosed with asthma and …

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Phase 3 fremanezumab trial in chronic cluster headache halted due to likely primary endpoint failure

A Phase 3 fremanezumab trial in chronic cluster headache has been halted early after a pre-specified futility analysis revealed that the primary endpoint (mean change from baseline in monthly average number of cluster headaches during 12 weeks treatment) was unlikely to be met. No safety concerns were observed. The study was part of the ENFORCE …

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Atogepant significantly reduced monthly migraine/probable migraine headache days in Phase 2b/3 study

Atogepant, the oral CGRP receptor antagonist being developed for migraine prevention by Allergan, has been shown to significantly reduce monthly migraine/probable migraine (MPM) headache days from baseline, compared to placebo. This primary endpoint of the 12-week Phase 2b/3 study (CGP-MD-01) in patients with episodic migraine was met for all doses and dose regimens of atogepant. …

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Phase 3 HALO data on fremanezumab in episodic migraine published in JAMA

Phase 3 HALO data demonstrating the efficacy of fremanezumab in patients with episodic migraine have been published in the Journal of the American Medical Association (JAMA). Compared to placebo, monthly fremanezumab reduced mean monthly migraine days by 1.5 days over a 12-week period, and a 1.3 day reduction was seen with single higher-dose treatment (p<0.001 …

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Aimovig (erenumab) approved for migraine prevention in US adults

Aimovig (erenumab) is the first CGRP receptor inhibitor to be approved for migraine prevention in adults in the US. Patients will self administer Aimovig 70 mg or 140 mg once a month via the SureClick autoinjector. The approval by the US Food and Drug Administration (FDA) was announced by Amgen and Novartis who co-market the …

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Galcanezumab has significant impact on episodic but not chronic cluster headache

A Phase 3 trial of galcanezumab in patients with episodic cluster headache has met its primary endpoint. Galcanezumab significantly reduced weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period (-8.7 for galcanezumab vs -5.2 for placebo, p=0.036). In contrast, a second Phase 3 study of galcanezumab …

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Migraine and tension-type headache may have more in common than classification criteria suggest

Migraine and tension-type headache (TTH) should be considered as aetiologically related conditions rather than the distinct entities defined by International Classification of Headache Disorders, 2nd edition (ICHD-II) criteria, according to results of a study exploring shared genetic and environmental factors of the two conditions. Using the Netherlands Twin Registry, researchers analysed data from 11,941 participants, …

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Migraine costs UK economy nearly £8.8 billion in lost productivity each year

Migraine is responsible for approximately 86 million lost workdays in the UK each year due to absenteeism and reduced effectiveness at work (presenteeism), according to a new report produced by the Work Foundation and funded by Novartis. The publication, Society’s Headache: The socioeconomic impact of migraine, concludes that this lost productivity costs the UK economy nearly £8.8 …

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ACHIEVE II meets primary endpoints with ubrogepant 50mg in acute migraine treatment

Significantly more migraine patients were free of pain and the most bothersome migraine symptoms, two hours after taking the oral CGRP inhibitor, ubrogepant 50mg, than those treated with placebo. These were the key findings reported by investigators taking part in the Phase 3, ACHIEVE II trial. Patients in the lower dose, ubrogepant 25mg group were …

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LIBERTY: full results confirm erenumab’s efficacy in migraine patients unresponsive to previous prophylaxis

Erenumab significantly reduces migraine frequency in patients with episodic migraine who have not responded to other preventive treatments, according to the LIBERTY study.  At the end of 12 weeks, patients taking erenumab had nearly three-fold higher odds of having their migraine days reduced by at least 50% (weeks 9-12: 30.3% with erenumab, 13.7% with placebo, …

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RAMP 1 antibody now available for migraine researchers

An anti receptor activity-modifying protein 1 (RAMP 1) antibody is now available for scientists investigating the role of calcitonin gene-related peptide (CGRP) in migraine. Validated by Dr Debbie Hay (member of the CGRP Forum Editorial Advisory Board) and colleagues, the antibody corresponds to a region within the human RAMP C-terminal protein sequence. Dr Hay comments: …

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Towards a brighter future for migraineurs

Progress in the fundamental understanding of migraine is leading to novel, mechanism-based and disease-specific treatments, according to a new expert review. The World Health Organization ranks migraine as the third most prevalent medical condition and the second most disabling neurological disorder in the world.  However, despite the availability of evidence-based guidelines, the management of migraine …

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Largest-ever analysis highlights long-term stroke and heart attack risk in migraine

An updated meta-analysis, including over 1 million subjects followed up for up to 26 years, concludes that migraine is associated with a higher long-term risk of cardiovascular and cerebrovascular events, an effect that is due to an increased risk of stroke (both ischaemic and haemorrhagic) and myocardial infarction (MI). After analysing a total of 16 …

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Women’s Health Study reveals link between migraine and endometriosis

An analysis of data from the Women’s Health Study reports that adolescents with endometriosis are more likely to experience migraines than young women without endometriosis.1 The cross-sectional study, conducted within the ongoing longitudinal cohort of the Women’s Health Study: From Adolescence to Adulthood,2 compared adolescents surgically diagnosed with endometriosis with a control group of adolescents …

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Burden of migraine falls heaviest on already disadvantaged people

In the USA, severe headache and migraine remain important public health problems that are more common and burdensome for women, particularly women of childbearing age, and other historically disadvantaged segments of the population. These are the conclusions of a systematic review of the most current publicly available summary statistics from the US National Health Interview …

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US analysis forecasts lower migraine-related costs and more QALYs with erenumab

Mathematical modelling of value-based pricing (VBP) concludes that, compared with supportive care, preventive treatment of migraine with erenumab is likely to result in lower direct and indirect costs, and incremental quality adjusted life years (QALYs). The model compared erenumab to no preventive treatment in episodic and chronic migraine patients who had failed at least one …

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Eurolight study reveals poor medical care for people with migraine in Europe

In wealthy European countries, too few people with migraine consult physicians, and migraine-specific medications are used inadequately even among patients who do seek medical advice. These are the main conclusions of the Eurolight study, a cross-sectional, questionnaire-based survey that recorded migraine prevalence and frequency, and utilisation of medical services and acute and preventive medications in …

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PREMIUM trial does not support patent foramen ovale closure in migraine prevention

In the randomised PREMIUM trial, patent foramen ovale (PFO) closure to prevent migraine did not meet the primary endpoint of a > 50% reduction in migraine attacks, with or without aura, compared to sham control. PREMIUM is a double-blind study that randomised 230 patients with migraine to medical therapy with a sham procedure (right heart …

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Abdominal migraine: important, common and an under-recognised cause of recurrent pain in children

This useful article reviews published evidence and advises on diagnosis and treatment of abdominal migraine (see Table). The condition usually starts in childhood, though it may occur in adults. It may be associated with, or followed by, other forms of migraine, and it predicts adult migraine. Recommended pragmatic clinical definition of abdominal migraine Episodic central …

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Migraine is a strong marker of cardiovascular risk, Danish study concludes

Migraine appears to be an important risk factor for most cardiovascular diseases, according to the results of a nationwide, population-based study from Denmark.1 The study compared 51 032 patients with migraine and 510 320 people from the general population matched on age, sex, and calendar year. After 19 years of follow-up, migraine was positively associated with: Myocardial …

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ACHIEVE I: pivotal phase 3 clinical trial achieves key goal for ubrogepant

Allergan has announced that the ACHIEVE I study has met its co-primary endpoints, with both doses of the oral CGRP receptor antagonist ubrogepant being significantly more effective than placebo in treating a single migraine attack. ACHIEVE I is a multicentre, randomised, double-blind, placebo-controlled, parallel group study that randomised 1327 adults. Patients were treated for a …

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Phase 3 ARISE trial confirms efficacy and safety of erenumab 70 mg monthly in episodic migraine

Prophylaxis with erenumab 70 mg monthly significantly reduces migraine frequency and acute migraine-specific medication use in patients with episodic migraine. These are the outcomes of ARISE, a double-blind, placebo-controlled that randomised 577 adults with episodic migraine to either placebo or 70 mg erenumab monthly. On the primary endpoint of change in monthly migraine days from baseline to …

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LIBERTY: positive results for erenumab in episodic migraine patients not responding to multiple prior preventive treatments

Novartis reports that the phase IIIb LIBERTY study has met its primary endpoint, with significantly more patients taking erenumab experiencing at least a 50% reduction from baseline in their monthly migraine days compared with patients receiving placebo. Safety outcomes are consistent with previous erenumab studies. Full results of LIBERTY will be presented at a future …

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Opioid should not be first choice for acute migraine in the emergency department

Intravenous (IV) hydromorphone is substantially less effective than IV prochlorperazine for the treatment of acute migraine in the emergency department, according to a randomised controlled trial. The study was conducted in two emergency departments in New York City. Patients who not used an opioid within the previous month were randomised either to IV hydromorphone 1 …

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Study highlights safety of galcanezumab in patients with episodic migraine

Treatment-emergent adverse events are primarily mild to moderate with galcanezumab, according to results of a multicentre, double-blind, randomised phase 2b study in episodic migraine. The study included 410 patients with episodic migraine, who received 5 mg, 50 mg, 120 mg or 300 mg of galcanezumab or placebo subcutaneously once daily for 12 weeks. This was followed …

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Higher risk of physical and mental comorbidities for people with chronic migraine

Comorbidity is more frequent among people with chronic migraine compared to controls, especially among those living in areas of higher socioeconomic deprivation. These are the conclusions of an analysis of cross-sectional primary healthcare data from Scotland.1 The researchers examined data on the presence of chronic migraine, 31 other physical conditions and seven mental health conditions …

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PROMISE 2: single quarterly infusion of eptinezumab significantly reduces monthly migraine days in chronic migraine

Alder Biopharmaceuticals has announced that the pivotal phase 3 PROMISE 2 clinical trial in chronic migraine has met the primary endpoint and all key secondary endpoints for both doses of the CGRP inhibitor eptinezumab. On the primary endpoint of mean change from baseline in monthly migraine days over the 12-week, double-blind treatment period, a single …

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Phase 3 study shows that erenumab once monthly reduces the impact of episodic migraine

Erenumab administered subcutaneously at a monthly dose of 70 mg or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities, and the use of acute migraine-specific medication over six months. These are the outcomes of the STRIVE phase 3 trial, published in the New England Journal of Medicine.1 STRIVE randomly assigned …

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Fremanezumab cuts headache frequency in chronic migraine in phase 3 study

Prophylactic subcutaneous fremanezumab, given monthly or quarterly, significantly reduces the number of monthly headache days in patients with chronic migraine, according to a phase 3 trial published in the New England Journal of Medicine.1 The study included 1130 patients with chronic migraine (headache of any duration or severity on ≥15 days per month and migraine on …

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Patient satisfaction is higher with migraine-specific acute treatments

Using a migraine-specific medication (a triptan or ergot) as initial treatment for acute migraine is associated with the greatest patient satisfaction and the lowest migraine-related disability. This is the conclusion of a three-month diary study involving 337 patients (92.5% female, 84% with episodic migraine).1 Based on 29,722 recorded diary days: Patients took acute medication on …

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Adverse events are higher with triptans than with other acute migraine treatments

Any adverse event or a treatment-related adverse event is more likely with triptans than with placebo and non-triptan acute migraine treatments, according to a systematic literature review. The review included 141 randomised controlled trials evaluating oral treatments for acute migraine: Sumatriptan, eletriptan, rizatriptan, zolmitriptan and the combination of sumatriptan and naproxen were associated with a …

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