"Erenumab" from_date:2012

Erenumab for preventing migraine Erenumab for preventing migraine Technology appraisal guidance Published: 10 March 2021 www.nice.org.uk/guidance/ta682 © NICE 2021. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Your responsibility Your responsibility The recommendations in this guidance represent the view of NICE, arrived at after . Erenumab for preventing migraine (TA682)© NICE 2021. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Page 2 of34Contents Contents 1 Recommendations ......................................................................................................................................................4 2 Information about erenumab

GVS advice CGRP inhibitors erenumab, fremanezumab, galcanezumab (Aimovig, AJOVY, Emgality) for the treatment of patients with episodic and chronic migraine GVS advice CGRP inhibitors erenumab, fremanezumab, galcanezumab (Aimovig®, AJOVY®, Emgality®) for the treatment of patients with episodic and chronic migraine | Report | National Health Care Institute Go to content You are here: Home Publications GVS advice CGRP inhibitors erenumab, fremanezumab, galcanezumab (Aimovig®, AJOVY®, Emgality®) for the treatment of patients with episodic and chronic migraine Search within English part of National Health Care Institute Search GVS advice CGRP inhibitors erenumab, fremanezumab, galcanezumab (Aimovig®, AJOVY®, Emgality®) for the treatment of patients with episodic and chronic migraineThe National

Erenumab (prophylaxis of migraine) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Erenumab (Migräne) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 January 2019). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-71 Erenumab (migraine) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A18-71 Version 1.0 Erenumab (migraine) 30 January 2019 Institute for Quality and Efficiency in Health Care

Early Use of Erenumab vs Nonspecific Oral Migraine Preventives: The APPRAISE Randomized Clinical Trial Patients with migraine often cycle through multiple nonspecific preventive medications due to poor tolerability and/or inadequate efficacy leading to low adherence and increased disease burden. To compare the efficacy, tolerability, patient adherence, and patient satisfaction between erenumab and nonspecific oral migraine preventive medications (OMPMs) in patients with episodic migraine (EM) who had previously failed 1 or 2 preventive treatments. The 12-month prospective, interventional, global, multicenter, active-controlled, randomized clinical trial comparing sustained benefit of 2 treatment paradigms (erenumab qm vs oral prophylactics) in adult episodic migraine patients (APPRAISE) trial

Efficacy and Safety of Erenumab for Nonopioid Medication Overuse Headache in Chronic Migraine: A Phase 4, Randomized, Placebo-Controlled Trial Patients with chronic migraine and medication overuse headaches (CM-MOH) represent a particularly burdened subpopulation. This trial provides first, to our knowledge, American Academy of Neurology class I evidence for a preventive therapy in CM-MOH . To assess erenumab efficacy and safety in patients with nonopioid CM-MOH. This randomized, double-blind, parallel-group, placebo-controlled trial took place at 67 centers in North America, Europe, and Australia from October 7, 2019, to November 2, 2022. This report reflects the primary analysis conducted in January 2023, using a database snapshot from December 1, 2022, which contains the complete dataset

Erenumab (Aimovig) for the prevention of migraine attacks: decrease in the frequency of attacks in some patients, but uncertainty over cardiovascular effects Prescrire IN ENGLISH - Spotlight ''Erenumab (Aimovig°) for the prevention of migraine attacks: decrease in the frequency of attacks in some patients, but uncertainty over cardiovascular effects '', 1 September 2019 {1}##LOC[OK]## {1} ##LOC * No conflicts of interest * Where to find us * About Prescrire International * Testimonials * Prescrire events * A global network Offers * Subscribe now * Solidarity Subscription Rate * Subscribers: register online * Prescrire's other products * Free Special Edition * Sign up to receive the newsletter english.prescrire.org > Spotlight > 100 most recent > Erenumab (Aimovig

Effect of erenumab versus other migraine preventive medications on cardiovascular and cerebrovascular outcomes: A United States claims database-based observational cohort study. To estimate the real-world risk of cardiovascular events among patients with migraine treated with erenumab and other migraine preventive medications. Migraine preventive treatment with calcitonin gene-related peptide (CGRP) pathway inhibitors, such as erenumab and others, may theoretically result in cardiovascular effects due to a lack of compensatory vasodilation with CGRP pathway inhibition. In this retrospective observational cohort study, we estimated the unadjusted cumulative risk (CR) of new-onset hypertension, acute myocardial infarction (MI), or stroke among patients with migraine newly treated

Improvement of Prurigo Nodularis With Erenumab. This case report describes a patient in her 50s with prurigo nodularis and itch at the elbows, which spread to all extremities, the trunk, and genital area.

Erenumab in a patient with persistent headaches after subarachnoid hemorrhage: A case report of an effective treatment. A patient with persistent refractory headaches from aneurysmal subarachnoid hemorrhage was treated with monthly erenumab injections, a monoclonal antibody to the calcitonin gene-related peptide (CGRP) receptor. These injections decreased the frequency and severity

Blood pressure elevation in erenumab-treated patients with migraine: A retrospective real-world experience. Erenumab is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) receptor and is approved for the preventative treatment of migraine in adults. CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension . While there has not been evidence of hypertension in preclinical models or clinical trials, post-marketing data suggest erenumab may be associated with hypertension. This led to a warning in the United States Food and Drug Administration prescribing information for erenumab. To determine the frequency of worsening blood pressure (BP) after initiation of erenumab in patients with migraine and how

No wearing-off effect of erenumab or fremanezumab for chronic migraine prevention: a single-center, real-world, observational study. The present study investigates the wearing-off effect in adults with chronic migraine treated with erenumab or fremanezumab. This real-world observational study was based on pre-collected headache diaries from chronic migraine patients in treatment with either monthly injections of 140 mg of erenumab or 225 mg of fremanezumab. Consistent wearing-off was defined as an increase of ≥2 weekly migraine days in the last week compared to the second week over two consecutive 4-week treatment periods. The primary endpoint was wearing-off in the total population. The secondary endpoints were difference in wearing-off in (i) a subgroup of patients treated with erenumab

Double-blind, randomized, placebo-controlled study to evaluate erenumab-specific central effects: an fMRI study. Given the findings of central effects of erenumab in the literature, we aimed to conduct a rigorous placebo-controlled, double-blind, randomized study to elucidate whether the observed changes are directly attributable to the drug. We recruited 44 patients with migraine, randomly assigning them to either the erenumab 70 mg or the placebo group. 40 patients underwent fMRI scanning using a trigeminal nociceptive paradigm both, pre- and four weeks post-treatment. Participants kept a headache diary throughout the whole study period of two months in total. A clinical response was defined as a ≥30% reduction in headache frequency at follow-up. Details of this study have been

Hypersensitivity to CGRP as a predictive biomarker of migraine prevention with erenumab. The present study aimed to investigate the predictive value of calcitonin gene-related peptide (CGRP)-induced migraine attacks for effectiveness to erenumab treatment in people with migraine. In total, 139 participants with migraine underwent a single experimental day involving a 20-min infusion with CGRP . Following this, the participants entered a 24-week treatment period with erenumab. The primary endpoints were the predictive value of CGRP-induced migraine attacks on the effectiveness of erenumab, defined as ≥50% reduction in monthly migraine days, or ≥ 50% reduction in either monthly migraine or monthly headache days of moderate to severe intensity. Among participants with CGRP-induced migraine attacks

Efficacy and Safety of Erenumab in Participants With Episodic Migraine in Whom 2-4 Prior Preventive Treatments Had Failed: LIBERTY 3-Year Study. The LIBERTY study assessed the efficacy and safety of erenumab in participants with episodic migraine (EM) and 2-4 prior preventive treatment failures. The results have been presented after 3 years of erenumab exposure in its open-label extension phase (OLEP). Participants completing the 12-week double-blind treatment phase (DBTP) of the LIBERTY study could enter the OLEP and receive 140 mg of erenumab once monthly for 3 years. The main outcomes included the proportion of participants achieving ≥50% reduction in monthly migraine days (MMDs), the mean MMD change from baseline, and tolerability and safety. Overall, 240/246 (97.6%) participants entered

Effect of erenumab on the reversion from chronic migraine to episodic migraine in an Asian population: A post hoc analysis of the DRAGON study. Erenumab is a fully human monoclonal antibody that selectively targets the calcitonin gene-related peptide receptor. It has been proven to be safe and efficacious in patients with episodic migraine (EM) and chronic migraine (CM) as demonstrated in phase 2 and 3 clinical trials including patients from Europe, Japan, and the United States. Reversion from CM to EM, as indicated by a reduction in the frequency of headache days, is an important indicator for efficacy outcome, though it has not been analyzed widely in patients with CM to date. Primary results of the DRAGON study demonstrated the efficacy and safety of erenumab in patients with CM from

Erenumab for Treatment of Persistent Erythema and Flushing in Rosacea: A Nonrandomized Controlled Trial. Treatment of erythema and flushing in rosacea is challenging. Calcitonin gene-related peptide (CGRP) has been associated with the pathogenesis of rosacea, raising the possibility that inhibition of the CGRP pathway might improve certain features of the disease. To examine the effectiveness , tolerability, and safety of erenumab, an anti-CGRP-receptor monoclonal antibody, for the treatment of rosacea-associated erythema and flushing. This single-center, open-label, single-group, nonrandomized controlled trial was conducted between June 9, 2020, and May 11, 2021. Eligible participants included adults with rosacea with at least 15 days of either moderate to severe erythema and/or moderate

Changes in use of acute and preventive medications for migraine after erenumab initiation over 12 months: A United States retrospective cohort study. To assess changes in real-world use of acute and preventive medications for migraine over a 12-month follow-up period in the United States following initiation of the anti-calcitonin gene-related peptide (CGRP) pathway monoclonal antibody (mAb ) erenumab. Early assessments of real-world use of acute and preventive medications for migraine after initiation of erenumab have been limited to 6 months of follow-up. This retrospective cohort study used data from the IQVIA open-source longitudinal prescription (LRx) and medical (Dx) claims databases. Adult patients with an initial claim (index date) for erenumab between May 2018 and April 2020 were

Assessment of prolonged safety and tolerability of erenumab in migraine patients in a long-term open-label study (APOLLON). Efficacy and safety of human monoclonal antibody erenumab used for migraine prophylaxis have been shown in clinical studies. APOLLON is an open-label, multi-center, single arm study, which permits dose adjustments of erenumab and includes an option for a drug holiday . The findings contribute to the accumulating long-term evidence regarding erenumab's tolerability and safety profile in individuals experiencing episodic and chronic migraines. The study population consisted of adult patients with episodic or chronic migraine, who had successfully completed the HER-MES study (NCT03828539). Patients were treated with erenumab for 128 weeks at a flexible dose of either 70 mg

Erenumab versus topiramate: migraine-related disability, impact and health-related quality of life. HER-MES was the first head-to-head study of erenumab against topiramate (standard of care). This post hoc analysis of the HER-MES study evaluated the effect of erenumab versus topiramate on patient-reported outcomes at week 24. Adult patients with episodic or chronic migraine (n = 777) were randomized (1:1) to monthly subcutaneous erenumab (n = 389) or daily oral topiramate (n = 388). Migraine-related disability, as measured by the Headache Impact Test 6 (HIT-6) and Short Form 36 Health Survey version 2 (SF-36v2), was analysed in the entire study cohort and true completers. In the erenumab group (vs. topiramate), significant improvements were reported in Headache Impact Test 6 total scores

Erenumab-aooe (Aimovig) - For the preventive treatment for migraine Drug Approval Package: Aimovig (erenumab-aooe) injection * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDADrug Approval Package: Aimovig (erenumab-aooe) injection * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print Company: Amgen, Inc.Application Number: 761077Approval