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

Vydura (rimegepant) has received EU marketing authorisation in the acute treatment of migraine with or without aura, and for the prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. Vydura orally disintegrating tablet is the first medicine approved for both acute and prophylactic treatment of migraine in the EU. “Vydura’s …

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Rimegepant linked to reduced opioid prescriptions and medication overuse headache

Significant reductions in opioid use and in medication overuse headache (MOH) have been reported from an analysis of prescription claims data from a longitudinal commercial pharmacy database in the months following rimegepant initiation for migraine. Eighteen month follow up data for the opioid use analysis showed a 16.06% reduction in total opioid prescriptions filled in …

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Atogepant attenuates activation of Aδ- and C-fibre meningeal nociceptors

Atogepant appears to partially prevent activation of both Aδ- and C-fibre meningeal nociceptors, according to results of a mechanistic study using single-unit recordings of activity in trigeminal ganglion neurons innervating the dura in response to cortical spreading depression (CSD). Atogepant did not fully prevent activation of nociceptors (incidence of response to CSD in Aδ-fibres [vehicle 73%, …

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Patients advised to start ubrogepant as soon as migraine headache starts

When a patient with migraine starts ubrogepant whilst their pain is mild, they are more likely to be free of pain and other symptoms after two hours than if they delay until their pain is moderate or severe. This is the conclusion of a post-hoc, within-person analysis of efficacy data from patients who treated at …

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Atogepant associated with decrease in body weight

Post-hoc analyses of data from studies of atogepant for migraine prevention have shown treatment-related, dose-dependent reductions in body weight compared with placebo and standard care.  In the ADVANCE trial, least squared (LS) mean percentage change in body weight from baseline to 12 weeks was +0.37 with placebo versus +0.14 (p=0.4138), -0.61 (p=0.0005), and -1.27 (p<0.0001) …

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Four or fewer monthly headache days proposed as treatment goal for chronic migraine

Patients with chronic migraine (CM) who reduce attacks to four or fewer monthly headache days achieve superior outcomes, with least need for acute medication. This is the conclusion of a post hoc analysis of data from the PROMISE-2 trial evaluating eptinezumab for CM prevention. The analysis showed that, of patient-months with ≤4 MHDs, 67.6% (561/830) …

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Fremanezumab efficacy and disability benefits following onabotulinumtoxinA treatment failure

Fremanezumab treatment resulted in clinically meaningful reductions in monthly migraine days (MMD) and significant improvements in disability outcomes in patients with prior onabotulinumtoxinA treatment failure. These were the findings from pooled data from the Phase 3 HALO EM, HALO CM, and FOCUS trials in which patients were randomized 1:1:1 to quarterly or monthly fremanezumab or …

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DRAGON data confirm erenumab efficacy and safety in chronic migraine in Asia

Safety and efficacy data from the DRAGON study of erenumab 70 mg in adult patients with chronic migraine in China and other Asian countries are consistent with previous pivotal studies. In the 12-week Phase 3 study of 557 patients with chronic migraine, those in the erenumab 70 mg group had a significantly greater reduction in …

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Zavegepant pharmacokinetic data support efficacy in migraine

Intranasal zavegepant in doses up to 40mg per day has demonstrated good safety and tolerability in healthy adults, with doses ≥10 mg producing exposures predictive of efficacy in adults with migraine.1 These results from two Phase 1, placebo-controlled, randomised, double-blind, sequential zavegepant studies provide supportive data following previous reports of Phase 3 data demonstrating significantly …

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Long-term galcanezumab data show sustained safety and tolerability

High completion rates and sustained safety and tolerability were reported from an open access programme for galcanezumab in patients who completed the 3-month double-blind and 9-month open-label phases of the Phase III REGAIN trial (NCT02614261). Patients entered the three year continuous access programme for galcanezumab approximately five to 13 months after their last study dose. …

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Qulipta (atogepant) study meets primary endpoint in chronic migraine

Qulipta (atogepant) significantly reduced mean monthly migraine days (MMDs) compared to placebo in adult patients with chronic migraine (CM), according to data announced from the Phase 3 PROGRESS trial. The results will support a submission to expand the use of atogepant to include preventive treatment of CM in the USA. The drug was approved for …

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Rimegepant en route to EU approval

Rimegepant 75 mg orally dissolving tablet is likely to get the go ahead for EU approval, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which advises the European Medicines Agency (EMA) on product approvals. Following a CHMP opinion, an approval decision is generally made within 10 weeks. The positive …

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Which patients in Brazil are suitable for anti-CGRP therapies and how do you follow up people on anti-CGRP therapies?

Professor Fernando Kowacs considers which patients may benefit from CGRP monoclonal antibodies and describes the factors that influence his choice of drug for individual patients as well as his approach to follow up, and his switching strategies for poor responders.  

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Rimegepant efficacy confirmed in Asia-Pacific study

Top-line data from a Phase 3 rimegepant trial for the acute treatment of migraine in 1,431 adult patients in China and South Korea have shown that the study met its co-primary endpoints. Two hours after a single dose of rimegepant 75 mg orally dissolving tablet, significant improvements were seen compared to placebo in freedom from …

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Vyepti (eptinezumab) approved for migraine prevention in Europe

Vyepti (eptinezumab) has received approval by the European Medicines Agency for migraine prevention in EU countries and will be the first intravenous CGRP monoclonal antibody (mAb) treatment available in Europe. Like other CGRP mAbs, eptinezumab has been approved for prophylactic treatment of migraine in adults who have at least four migraine days per month. The …

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Phase 3 zavegepant trial demonstrates acute pain relief in migraine

Top-line Phase 3 data on the investigational, intranasal agent, zavegepant, as acute treatment of migraine have demonstrated significantly greater improvement in pain freedom and most bothersome symptom than placebo. The study achieved its co-primary regulatory endpoints of pain freedom (zavegepant 24% vs placebo 15%, p<0.0001) and freedom from most bothersome symptom (zavegepant 40% vs placebo …

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

Patients with episodic migraine are being enrolled in CHALLENGE-MIG – a Phase 4, head-to-head study of the CGRP mAb injection, galcanezumab, and the oral gepant, rimegepant. The primary endpoint is the percentage of patients with ≥50% reduction from baseline in monthly migraine headache days. Secondary endpoints include quality of life and migraine disability improvements and …

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

Full data from the HER-MES trial showing that significantly fewer patients with episodic or chronic migraine discontinued erenumab 70 or 140 mg/month than topiramate 50-100 mg/day, and more patients achieved > 50% reduction in monthly migraine days (MMDs), have been published in Cephalgia. In the Phase 4, 24-week study which enrolled 777 adult patients, 10.6% …

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European biomarker study seeks response indicators for CGRP mAbs

Identifying patients most likely to respond to CGRP mAbs will be key to improving access to this important group of new drugs, and a study in Italy, Germany and Spain is investigating an array of demographic, clinical, psychological, cognitive, epigenetic, pharmacogenetic, biochemical and imaging markers. “We are not expecting to see a single biomarker that …

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Ligand- and receptor-binding CGRP mAbs are equally effective

There is no difference in efficacy between ligand- and receptor-binding CGRP mAbs and there is no evidence that any one mAb works better than another, agreed speakers in response to questions at a joint session of the World Federation of Neurology and the International Headache Society. “Based on Phase 3 clinical studies, we don’t see …

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Changing migraine patterns after erenumab and influence of personality and stress

One in three patients treated with erenumab at an Italian centre reverted from chronic to episodic migraine after one month, and 71% by the end of one year of treatment, reported Dr Gloria Vaghi, from the University of Pavia, Italy. The real world study, in 82 patients with chronic migraine who had failed on at …

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Response to fremanezumab in Korean patients compares well with pivotal HALO studies

Reduction in migraine headache days in patients treated with fremanezumab in Korea compares well with reductions seen in the pivotal Phase 3 HALO studies in episodic and chronic migraine. Results of two phase 2b/3 studies in Korea, with the same design as the HALO trials, showed similar reductions in monthly headache days (MHDs) and responder …

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Rapid effects of CGRP mAbs highlighted in real world study

Nearly six out of 10 patients with chronic migraine had a significant clinical response to erenumab or galcanezumab in the first four weeks of treatment in a retrospective real world study reported from ASST Spedali Civili Brescia, Italy. Of the 74 consecutive patients who were enrolled, 64 had documented medication overuse, and 50 patients were …

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Fewer patients discontinue CGRP mAbs than other migraine preventives

Patients taking CGRP mAbs are less likely to discontinue treatment within 12 months than those taking other approved preventive therapies for migraine, according to US claims data from over 4,500 patients prescribed CGRP mAbs and nearly 11,000 taking other preventives. Over a 12-month follow-up, 58.8% of CGRP mAb and 77.6% of non‑CGRP initiators discontinued therapy …

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Qulipta (atogepant) approved for episodic migraine in USA

The US Food and Drug Administration (FDA) has approved the oral CGRP receptor antagonist, Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. The drug will be available as once-daily treatment in three doses – 10 mg, 30 mg and 60 mg. The approval is supported by data evaluating the efficacy, safety and …

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Combining CGRP mAbs and gepants: what do we know?

Since the US approval of the first gepant for the acute treatment of migraine in December 2019, clinicians have been reporting their experiences of combining these agents with CGRP monoclonal antibodies (mAbs) in some patients. Richard Lipton, Edwin S Lowe Professor of Neurology at the Albert Einstein College of Medicine, New York, USA, discusses the …

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Using real world evidence to guide CGRP antibody prescribing

Real world studies are showing that CGRP mAbs are effective in significant patient groups excluded from randomised controlled trials (RCTs). They are also helping to identify predictors of treatment response and are extending understanding of safety issues. Professor Uwe Reuter, from the Charité University Berlin and the University of Greifswald, Germany, discussed data from the …

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Stopping CGRP mAb therapy leads to worsening migraine

Stopping preventive treatment with CGRP mAbs typically leads to worsening migraine symptoms and, in some cases, a rebound effect, according to reports from clinicians in Germany, Portugal and Italy. Results of a German longitudinal study of 62 patients who received erenumab, fremanezumab or galcanezumab for at least eight months showed that mean monthly migraine days …

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Fremanezumab has minimal blood pressure effects in long term trials

Twelve month data from the HALO study and six month results from the FOCUS study have shown few blood pressure-related adverse events with fremanezumab and minimal changes in systolic blood pressure (SBP) or diastolic blood pressure (DBP). In HALO, one patient had increased DBP and one had decreased SBP, both with quarterly fremanezumab. Mean blood …

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Erenumab and galcanezumab show similar efficacy and safety in hard-to-treat migraine

Erenumab and galcanezumab have demonstrated similar efficacy and safety as preventive treatment in a very difficult-to-treat migraine population in Spain. Data were reported on 220 patients, 89% of whom had chronic migraine. Patients had failed on a mean 5.74 previous preventive therapies. With erenumab, monthly headache days (MHDs) decreased from 20.94 days at baseline to …

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Acute rimegepant treatment reduces migraine days

Long term acute treatment of migraine with rimegepant 75 mg as needed is associated with clinically relevant reductions in monthly migraine days (MMDs), according to post hoc results from an open label, 52-week safety study. There was no evidence of medication-related increases in headache frequency. In the study of 1,044 participants with ≥6 MMDs, the …

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Real world support for CGRP antibodies in cluster headache

Real world experience from multiple new reports worldwide supports the use of CGRP mAbs in the treatment of cluster headache. From Korea, researchers reported results from 45 patients with episodic cluster headache who received at least one dose of galcanezumab 240 mg in two prefilled syringes of 120 mg.1 Patients took a range of preventive …

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ADVANCE open label extension confirms atogepant safety profile

No new safety signals have been identified in the ADVANCE open label extension study of atogepant 60 mg once daily for 40 weeks, with a 4-week safety follow-up period. Of the 685 patients who rolled over from the ADVANCE trial and took at least one dose of study drug, 74.6% completed the 40-week treatment period. …

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Up to one in three CGRP mAb non-responders may benefit from switching antibody

Approximately one in three non-responders to initial CGRP mAb treatment may benefit from switching to another antibody, according to results of two real world reports. In a retrospective cohort study of 25 non responders to erenumab (<30% reduction of monthly headache days [MHD] after three cycles), eight patients (32%) achieved a >30% reduction in MHD after switching …

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Patients very satisfied with ubrogepant pain relief

High levels of patient satisfaction have been reported in an analysis of data from 302 US adult Migraine Buddy users who self-reported using at least four doses of ubrogepant, one in the preceding 14 days. Of the sample, 75.8% reported being satisfied with ubrogepant for pain relief at 2 hours, 83.4% at 4 hours and …

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EARLY 2 study shows long term, real world efficacy and safety of erenumab

Long-term, real world experience with erenumab in high frequency episodic migraine (HFEM) and chronic migraine (CM) has shown sustained effectiveness, safety and tolerability in patients who failed on at least three previous preventive therapies. The results, from the 48-week EARLY 2 study in 15 Italian centres, also showed that responsiveness was positively associated with cutaneous …

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ADVANCE trial of atogepant published in New England Journal of Medicine

The ADVANCE study showing that atogepant significantly reduced mean monthly migraine days (MMDs) over 12 weeks has been published in the New England Journal of Medicine. In the efficacy analysis of 873 patients, MMDs were reduced from a baseline of 7.5-7.9 days by 3.7 days with atogepant 10 mg, 3.9 days with atogepant 30 mg …

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Ajovy and Emgality granted PBS status in Australia

Ajovy (fremanezumab) and Emgality (galcanezumab) have been approved for inclusion on the Pharmaceutical Benefits Scheme (PBS) in Australia for prescription to patients with chronic migraine. This means that the cost of treatment will be subsidised by the Australian government. Patients will need to fulfil three criteria to benefit from reduced pricing: A diagnosis of chronic …

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Erenumab benefits in refractory chronic migraine

Erenumab may be an effective and well tolerated therapy for patients with medically refractory, chronic migraine with and without medication overuse, according to results of a prospective single centre real world audit of patients treated for six months. The 162 patients in the audit had failed a mean of 8.4 preventive treatments at baseline, and …

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Patients respond to anti-CGRP mAbs irrespective of previous botulinum toxin A effects

In complex patients with multiple treatment failures, good responder rates are seen with anti-CGRP mAbs irrespective of previous poor response to botulinum toxin A (BTX-A), but dual therapy with anti-CGRP mAbs and botulinum toxin A does not appear to add more benefit compared to anti-CGRP mAb monotherapy.1 These were the findings from a real world …

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Migraine experts urge head-to-head prevention studies

European migraine specialists have urged head-to-head studies of preventive therapies, including CGRP monoclonal antibodies (mAbs), topiramate and botulinum toxin A. This follows two recent systematic reviews with meta-analyses showing that all three treatments have superior efficacy to placebo but topiramate has a less favourable safety profile and higher drop out rate compared to the other …

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

Galcanezumab significantly reduces mean weekly total pain burden in patients with episodic cluster headache, according to results of a post hoc analysis of the Phase 3 study which supported US approval of galcanezumab in the indication. The new analysis, aimed at addressing the multiple pain dimensions that may contribute to the total burden of episodic …

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Clinicians urged to report experience of switching patients between CGRP mAbs

Clinicians are being encouraged to report experiences of switching patients between CGRP mAbs in order to better understand potential benefits and inform treatment access policies of payers and care providers. A report of seven patients with chronic migraine and prior treatment with three to 14 preventive drugs (mean 9.5) has demonstrated the impact of switching …

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Restless legs syndrome reported with CGRP mAbs

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

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