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NICE to re-examine decision to reject Aimovig (erenumab) use on NHS in England

The National Institute for Health and Care Excellence (NICE) is to consider data related to the cost effectiveness of Aimovig (erenumab) in patients with chronic migraine who have failed treatment with botulinum toxin or when the toxin is contraindicated.1 This follows an appeal against NICE guidance issued last year to reject all use of erenumab …

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US patients to get autoinjector for Ajovy (fremanezumab)

US patients will soon be able to administer Ajovy (fremanezumab) through an autoinjector instead of a syringe. This follows US Food and Drug Administration (FDA) approval for the device to be used with fremanezumab for migraine prophylaxis. “Ajovy is the only FDA-approved anti-CGRP that offers the flexibility of quarterly (675 mg) or monthly (225 mg) …

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Positive top-line fremanezumab results for migraine prevention in Japanese studies

Preliminary results from two Phase 2/3 trials of fremanezumab in Japan have indicated that primary endpoints were achieved with statistical significance versus placebo in patients which chronic migraine and episodic migraine. Improvements versus placebo were also shown for secondary endpoints. No clinically significant adverse events were observed in patients who received fremanezumab. Fremanezumab is being …

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Ajovy (fremanezumab) prescription agreed for migraine prophylaxis in Scotland

Ajovy (fremanezumab) can be prescribed on the National Health Service (NHS) in Scotland for patients with chronic or episodic migraine who have failed on three or more preventive treatments, following a decision from the Scottish Medicines Commission (SMC).1 The ruling is based on the results of three phase 3 studies showing superiority of fremanezumab over …

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Vazegepant shows efficacy in acute migraine treatment

Intranasal vazegepant 10 and 20 mg doses were statistically superior to placebo in achieving freedom from pain and the most bothersome symptom two hours after administration, according to results of a dose ranging Phase 2/3 study in 1673 patients with acute migraine. Pain freedom at two hours was 15.5% with placebo compared to 19.6% with …

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CGRP switching may improve response

Switching non-responders to a CGRP monoclonal antibody (mAb) to a different anti-CGRP agent may elicit a better response, say researchers from Germany in a letter published in Headache. They report on three patients, two with chronic and one with episodic migraine, who benefitted from the change of treatment. No response had been seen to erenumab …

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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. January 2020 update No evidence of liver toxicity with supratherapeutic ubrogepant dosing. Ankrom W, Bondiskey P, …

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Ubrelvy (ubrogepant) receives US approval for acute migraine treatment

Ubrelvy (ubrogepant) has become the first oral CGRP receptor antagonist (gepant) to be approved for the acute treatment of migraine. The US Food and Drug Administration (FDA) has licensed ubrogepant for the acute treatment of migraine with or without aura in adults. “The FDA’s approval of Ubrelvy, a new oral option that is effective in the acute …

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Fresh insights on site of action for CGRP therapy

CGRP monoclonal antibodies (mAbs)and gepants may exert their effects at sites of axon to axon interaction between C-fibres and Aδ fibres in the trigeminal ganglion (TG) and the dura mater, according to newly published research. The trigeminal system has long been suggested as a possible site of action for CGRP MAbs but the precise location …

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Study casts new light on migraine signalling pathway

A new study of migraine induction has shown that two different intracellular signalling pathways trigger similar attacks within the same patients, suggesting that the pathways converge and there is a common driver of attacks. In a group of 34 patients, migraine was induced using CGRP on one day and sildenafil on another. CGRP is known …

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Neuropeptide study suggests missing link between migraine and opioid overuse pain

Analysis of more than 1500 neuropeptides in brain tissue from animal models of migraine and opioid-induced hyperalgesia (OIH) has identified 16 peptides whose levels were altered between the two conditions. As might be expected, CGRP was among seven peptides associated with chronic migraine, but it was not amongst the pain-processing peptides affected in OIH. Pituitary …

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Three-year erenumab data support safety and tolerability

Interim data from a five-year open label extension study of erenumab in episodic migraine have demonstrated a similar safety and tolerability profile at three-plus years to that seen in short-term placebo-controlled trials (NCT01952574). Recently published longest-term results for an anti-CGRP therapy show an exposure-adjusted adverse event (AE) patient incidence rate for erenumab of 132/100 patient-years, …

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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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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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