CGRP Education & Research Forum
Already a member? Become a member Register
youtubeLinkedIn
News

US migraine experts urge easier access to anti-CGRP therapies during COVID-19 crisis

Leading US migraine specialists have called on insurance providers to eliminate prior authorisation and step therapy requirements for migraine treatment during the COVID-19 crisis and enable easier access to anti-CGRP therapies for appropriate patients. In an editorial accepted for publication in Headache, Dr Christina Szperka and colleagues suggest that, at such a difficult time, patients …

Read more »

Nurtec (rimegepant) shows benefits in migraine prevention

Oral rimegepant 75 mg every other day significantly reduces monthly migraine days compared to placebo in patients with episodic or chronic migraine, according to results of a pivotal Phase 3 trial reported by Biohaven. The company now plans to submit rimegepant for regulatory approval for preventive treatment of migraine with the aim of it becoming …

Read more »

New research underlines CGRP role in trigeminal neuralgia

With early studies of anti-CGRP therapy underway in trigeminal neuralgia (TN), newly published research supports a role for CGRP in the pathophysiology of the disease and for CGRP inhibition in the analgesic mechanism of botulinumtoxinA (BTX-A) in TN. In a pilot study completed by 45/47 patients with classical TN and 30/47 matched healthy controls, plasma CGRP levels …

Read more »

Galcanezumab as an option after botulinum toxin failure

A post hoc analysis of galcanezumab data from the EVOLVE-1, EVOLVE-2 and REGAIN trials suggests that the CGRP antibody may be a useful next step for patients with migraine who fail to respond to onabotulinumtoxinA preventive therapy. Pooled data from 2886 patients with episodic or chronic migraine included 129 patients who failed onabotulinumtoxinA, with most …

Read more »

Could GLP-1 agonists help patients with anti-CGRP therapy related constipation?

Measurement of glucagon-like peptide-1 (GLP-1) and GLP-1 metabolite levels in patients taking anti-CGRP therapies could provide useful insights into whether GLP-1 supplementation may benefit those with treatment-associated constipation. This suggestion comes in a letter from leading Danish migraine researchers published in the Journal of Headache and Pain.1 Previous research has demonstrated CGRP-induced GLP-1 secretion and …

Read more »

Vazegepant moves towards Phase 3 trial in acute migraine

The intranasal CGRP antagonist, vazegepant, is expected to enter a Phase 3 clinical trial for the acute treatment of migraine after non clinical and Phase 2 issues were successfully addressed with the US Food and Drug Administration (FDA). Biohaven, which is developing the drug, expects to advance the 10 mg dose of intranasal vazegepant into …

Read more »

NICE recommends Ajovy (fremanezumab) use on NHS in England

The National Institute for Health and Care Excellence (NICE) has recommended approval for Ajovy (fremanezumab) for the preventive treatment of migraine in adults on the NHS in England.1 This means that up to 10,000 people may benefit from treatment. The draft guidance recommends that fremanezumab can be used for preventing chronic migraine in people who …

Read more »

Emgality (galcanezumab) refused EU approval for episodic cluster headache

The European Medicines Agency (EMA) has refused a licence extension for Emgality (galcanezumab) for the prevention of episodic cluster headache.1 The Committee for Medicinal Products for Human Use (CHMP), which advises the EMA, said that the single study used to support the application “did not show clearly that Emgality is effective for preventing attacks” in …

Read more »

Nurtec ODT (rimegepant) receives US approval for acute migraine treatment

Nurtec ODT (rimegepant) has been approved by the US Food and Drug Administration for the acute treatment of migraine with or without aura in adults. Nurtec ODT is formulated as a rapidly disintegrating tablet and the recommended dose is 75 mg taken orally. This is also the maximum recommended dose during a 24-hour period. The …

Read more »

US report supports likely cost effectiveness of ubrogepant and rimegepant

The Institute for Clinical and Economic Review (ICER) has concluded that, in patients with moderate-to-severe migraine for whom triptans are not effective, not tolerated or contraindicated, ubrogepant and rimegepant do not exceed commonly accepted thresholds for cost effectiveness in the USA. In a new report, ICER – a US independent non-profit research organisation that reports …

Read more »

Vyepti (eptinezumab) approved for migraine prevention in USA

Vyepti (eptinezumab) has been approved by the US Food and Drug Administration (FDA) for the preventive treatment of migraine in adults and will be available in April 2020. The recommended dose is 100 mg iv every three months, though some patients may benefit from a dose of 300 mg iv. The approval was supported by …

Read more »

Galcanezumab data published for chronic cluster headache

The failure of galcanezumab to significantly improve outcomes for patients with chronic cluster headache (cCH) suggests a distinct biology for the disease and underlines the significant unmet need for safe, effective, and well-tolerated preventive treatment. These are the conclusions of investigators reporting results of the Phase 3, 12-week, double-blind, placebo-controlled trial of galcanezumab in cCH.1 …

Read more »

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 …

Read more »

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) …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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, …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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, …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 – …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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], …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »

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 …

Read more »