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Novartis withdraws Aimovig reimbursement submission in Australia

Novartis has decided not to pursue a third attempt to gain reimbursement for Aimovig (erenumab) in Australia under the Pharmaceutical Benefits Scheme (PBS). The company has withdrawn its application to the Pharmaceutical Benefits Advisory Committee (PBAC) which recommends new medicines for listing on the PBS. The PBS lists all medicines in Australia that can be …

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CGRP IN THE JOURNALS

Are you looking for a specific study of anti-CGRP therapy or just want a quick update of recently published research? Take a look at our summary of some of the most important CGRP publications of the last 12 months.   First major publication of clinical trial data on ubrogepant: Goadsby PJ, Tepper SJ, Watkins PB et al. …

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NICE rejects Aimovig (erenumab) use on NHS in England

The National Institute for Health and Care Excellence (NICE) has ruled that Aimovig (erenumab) should not be available on the National Health Service (NHS) in England.1 Despite new cost effectiveness analyses submitted by erenumab manufacturer, Novartis, after draft guidance rejected the drug in January2,3, NICE has confirmed its previous decision. NICE said that although evidence …

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Eptinezumab is focus of planned Lundbeck takeover of Alder BioPharmaceuticals

Eptinezumab, the quarterly i.v anti-CGRP therapy developed by Alder Biopharmaceuticals, is the focus of a planned takeover of the company by Lundbeck for nearly $2 billion. Lundbeck plans to develop and launch eptinezumab worldwide, following the first expected approval of the drug for migraine prevention in the USA in early 2020. Subsequent regulatory submissions are …

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Migraine Awareness Week (1-7 September) – campaigning for change

During this year’s Migraine Awareness Week in the UK, advocates are raising the profile of migraine as a complex neurological condition and working to dispel the idea that it’s ‘just a headache’. Leading the campaign, the Migraine Trust is also urging employers to create workplaces that are ‘Mindful of Migraine’ – encouraging them to learn …

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Tear fluid offers new insights to CGRP activity in patients with migraine

Increased CGRP levels have been reported in tear fluid in patients with episodic and chronic migraine – offering a less invasive route to information about CGRP activity than plasma sampling. In a study of 45 patients with episodic and 45 with chronic migraine, CGRP levels in tear fluid were approximately 140 times higher than plasma …

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Emgality (galcanezumab) effective in patients who failed previous preventive migraine therapies

Top-line data from the Phase 3 CONQUER trial have shown that Emgality (galcanezumab) significantly reduced monthly migraine headache days in patients with episodic or chronic migraine who had previously failed on two to four types of standard migraine prevention for efficacy or safety/tolerability reasons. Galcanezumab reduced monthly migraine headache days by 4.1 days compared with …

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Wake up to World Brain Day – 22 July 2019

This year’s World Brain Day on Monday, 22nd July is focusing on migraine and its disabling, disruptive effects on the everyday lives of patients and their families. The World Federation of Neurology is urging clinicians to share the painful truth that migraine is under-recognised, under-diagnosed and under-treated and to work together to ensure that those …

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Rimegepant moves into trigeminal neuralgia trials

A Phase 2 efficacy and safety trial has started of rimegepant in the treatment of refractory trigeminal neuralgia. The study, underway at Johns Hopkins Medical Center, Baltimore, USA, has a double-blind, placebo-controlled, crossover design and is enrolling patients who failed to respond adequately to pharmacotherapy.  The primary outcome measure is the change in a patient’s …

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Emgality (galcanezumab) gains US approval for episodic cluster headache treatment

Emgality (galcanezumab) has become the first CGRP antibody to be licensed for the treatment of episodic cluster headache in adults in the USA. The approval is based on data including results of a Phase 3 study showing that patients taking galcanezumab experienced an average of 8.7 fewer weekly cluster headache attacks over weeks 1 to …

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Ajovy (fremanezumab) trial halted in episodic cluster headache

Clinical development of Ajovy (fremanezumab) for the treatment of episodic cluster headache has stopped following disappointing results from a pre-specified futility analysis of a Phase 3 trial in the drug’s ENFORCE programme. This showed that the study’s primary endpoint of mean change from baseline in the weekly average number of cluster headache attacks during the …

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Aimovig (erenumab) available for chronic migraine prophylaxis on NHS in Scotland

The Scottish Medicines Consortium (SMC) has ruled that adult patients with chronic migraine who have failed on at least three prior prophylactic treatments can be prescribed erenumab on the National Health Service (NHS).1 The SMC decision has taken account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of erenumab, and …

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CGRP may help explain why migraine is more common in women

Women may be more sensitive to raised levels of CGRP than men, suggest new pre-clinical findings reported by US researchers. The results, from a study of pain responses in female rodents, may help explain why migraine is three times more common in women than men. In behavioural models, dural injection of CGRP at doses of …

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Phase 2/3 study of BHV-3500 gets underway in acute treatment of migraine

Intranasal BHV-3500 is administered using the Aptar Pharma Unit Dose System (UDS) designed to enable systemic delivery of drugs. The device is approved with multiple drug products marketed in the United States using the Aptar technology. (Photo credit: Aptar Pharma)[/caption]The first patient has been enrolled in a Phase 2/3 double-blind, randomised, placebo-controlled, dose-ranging trial of …

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Ajovy (fremanezumab) approved for migraine prevention in Europe

The European Commission has granted Marketing Authorisation for Ajovy (fremanezumab) 225 mg for prophylaxis of migraine in adults who have at least four migraine days per month – the same indication approved for Aimovig (erenumab)1 and Emgality (galcanezumab).2 Fremanezumab, which has been developed by Teva, is the first anti-CGRP therapy available in Europe that is …

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Ubrogepant licence application for acute migraine treatment accepted by FDA

The US Food and Drug Administration (FDA) is considering ubrogepant for approval as the first oral CGRP antagonist for the acute treatment of migraine. The FDA has accepted the new drug application (NDA) for ubrogepant and has up to 10 months to approve it. The application is supported by data from four clinical trials – …

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European Headache Federation publishes CGRP therapy guidelines

New guidance from the European Headache Federation has concluded that CGRP monoclonal antibodies are promising agents for migraine prevention, though real-world data will be important to support their efficacy and safety, especially in the long term. Biomarker research is also needed to identify patients most likely to respond. For episodic migraine (EM), the guidance evaluated …

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Normal CGRP levels reported in patients with medication-overuse headache

New data showing normal levels of CGRP and nociceptin in patients with medication-overuse headache (MOH) underline the importance of identifying and treating MOH in patients with chronic headache. In a study of 17 patients with MOH, the majority with chronic migraine, no differences were found in CGRP and nociceptin levels compared with 30 sex and …

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Emgality (galcanezumab) receives US priority review for episodic cluster headache prevention

Emgality (galcanezumab) is undergoing Priority Review by the US Food and Drug Administration (FDA) for the preventive treatment of episodic cluster headache in adults. This follows the Breakthrough Therapy Designation that the drug received from the FDA for the indication in September 2018. Priority Review aims to speed up assessment of licence applications for drugs …

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Alder files for US approval of eptinezumab

Alder Pharmaceuticals has submitted a biologics licence application to the US Food and Drug Administration (FDA) for approval of eptinezumab in migraine prevention. If approved, the company plans to launch the drug in early 2020. The eptinezumab submission is supported by data from studies including the Phase 3 PROMISE 1 and 2 trials which showed …

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CGRP trial meta analysis focuses on responder rates

It’s still early days for meta analyses of CGRP clinical trial data, but a recently published pooled analysis of data from over 3000 participants in Phase 2 and 3 studies of erenumab, fremanezumab and galcanezumab has reinforced previously reported beneficial effects on responder rates. CGRP inhibitor treatment significantly improved both 50% responder rate (OR = 2.42, 95% CI = [2.04, 2.87], …

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New studies report contrasting findings on link between age of migraine onset and stroke risk

Increased stroke risk in people with migraine has been reported in multiple studies,1 and previous research has suggested that those who develop migraine at a young age are at greatest risk. However, data from a post hoc analysis from the Atherosclerosis Risk in Communities (ARIC) study have shown that individuals who developed migraine with aura …

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NICE postpones erenumab appraisal discussion in response to large volume of comments

The National Institute for Health and Care Excellence (NICE) in England has announced that it will reschedule discussion of its erenumab (Aimovig) appraisal owing to the high volume of comments received following publication of its draft guidance last month. Erenumab was to have been discussed at a NICE meeting on Thursday, 14 February, but NICE …

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Ajovy (fremanezumab) moves closer to EU approval

Ajovy (fremanezumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which advises the European Commission on market authorisation of new medicines. The CHMP has announced that fremanezumab will be available as a 225 mg solution for injection and, in line with other CGRP inhibitors recently approved for use …

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Draft NICE guidance rejects NHS use of Aimovig (erenumab) in England

Draft guidance from the National Institute for Health and Care Excellence (NICE) has said that Aimovig (erenumab) is not a cost effective use of National Health Service (NHS) resources in England for preventing chronic and episodic migraine in adults who have four episodes or more of migraine every month and where at least three other …

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Fremanezumab reduces migraine days in non-responders to multiple preventive drug classes

Top-line data from the Phase IIIb FOCUS study show that fremanezumab significantly reduced monthly average migraine days in patients with chronic or episodic migraine who previously had inadequate responses to two to four classes of preventive therapies. In the study of 838 patients, reductions in monthly average number of migraine days were -0.6 days with …

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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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