Aimovig (erenumab-aooe) / Amgen, Novartis 
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 12 Diseases   17 Trials   17 Trials   2487 News 


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  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Trial completion date, Trial primary completion date:  CHERUB01: Efficacy of Erenumab in Chronic Cluster Headache (clinicaltrials.gov) -  Mar 31, 2023   
    P2,  N=118, Recruiting, 
    Trial completion date: Apr 2023 --> Nov 2023 | Trial primary completion date: Mar 2023 --> Sep 2023
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Trial completion date, Trial primary completion date:  Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder (clinicaltrials.gov) -  Mar 28, 2023   
    P2,  N=30, Recruiting, 
    Trial completion date: Apr 2023 --> Nov 2023 | Trial primary completion date: Mar 2023 --> Sep 2023 Trial completion date: Jan 2023 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Sep 2023
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Journal, Real-world evidence, Real-world:  Monoclonal antibodies for chronic migraine and medication overuse headache: A real-world study. (Pubmed Central) -  Mar 21, 2023   
    In the 3 months follow-up after starting the treatment, both groups presented headache frequency reduction, but those with monoclonal antibodies had a significantly higher reduction in the number of headache days and symptomatic medication intake when compared to the control (p < 0.0001). The addition of an anti-CGRP monoclonal antibody to the treatment for medication overuse headaches in chronic migraineurs may result in decreasing headache frequency and symptomatic medication use when compared to conventional treatments with drugs.
  • ||||||||||  Journal:  Anti-calcitonin generelated peptide (CGRP) therapies for migraine (Pubmed Central) -  Mar 15, 2023   
    Indeed, these drugs present a risk in case of cardiovascular disease, by inhibiting vasodilation, and are therefore contraindicated in this population. The main limitation to the use of these treatments in France at present is the lack of reimbursement, the cheapest molecule being available at a price of 245
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Observational data, Retrospective data, Journal:  Predicting response to CGRP-monoclonal antibodies in patients with migraine in Japan: a single-centre retrospective observational study. (Pubmed Central) -  Mar 13, 2023   
    The main limitation to the use of these treatments in France at present is the lack of reimbursement, the cheapest molecule being available at a price of 245 Patients with migraine who are older, with fewer prior treatment failures and no past history of immuno-rheumatologic disease, may respond well to CGRPmAbs.
  • ||||||||||  Trudhesa (dihydroergotamine mesylate intranasal) / Impel Pharma, Aimovig (erenumab-aooe) / Amgen, Novartis
    Safety and Efficacy of Concomitant Erenumab and INP104 Use From the Phase 3 STOP 301 Study in Migraine Patients (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_4149;    
    At months 1, 2, 3, 4, 5, and 6, 32.3% and 54.3%, 37.1% and 70.8%, 33.3% and 50.0%, 40.3% and 68.1%, 28.0% and 42.7%, and 26.7% and 33.3% self-reported 2-hour pain and MBS freedom post-INP104, respectively. Conclusions Results suggest that INP104 may be an effective and well-tolerated acute therapy for migraine patients who concomitantly use erenumab as a preventive therapy, with sustained benefits over 6 months.
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Real-Life Experience with Erenumab Therapy in the Episodic and Chronic Migraine. (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_3976;    
    Conclusions At the end of study, we reported a statistically significant reduction in the mean number of monthly headache days, acute medication use per month, and improvement of quality of life. Results of this real-world setting are comparable to results of clinical trials.
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Efficacy and tolerability of anti-CGRP monoclonal antibodies in patients aged ?65 years with episodic or chronic migraine (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_2777;    
    Conclusions Eptinezumab had similar persistency with treatment to onabotulinumtoxinA, which was higher than subcutaneous CGRP mAbs. Conclusions This retrospective analysis provides real-world evidence that treatment with erenumab, fremanezumab, and galcanezumab is as efficacious and well-tolerated
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva
    Switching from galcanezumab to fremanezumab in migraine patients: a retrospective analysis (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_2776;    
    Background Three anti-CGRP monoclonal antibodies, galcanezumab, fremanezumab, and erenumab became available in Japan in 2021, galcanezumab was launched about four months before the other two drugs. Mean decreases in MMD from baseline right before switching (3-4 months after galcanezumab treatment), 1 month after switching, and 4 months later are 6.9 (p = 0.002), 7.9 (p < 0.001), and 6.2 (p = 0.008), respectively.
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Efficacy and Safety of Anti-CGRP Monoclonal Antibodies for Migraine Preventative Treatment (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_2602;    
    Mean decreases in MMD from baseline right before switching (3-4 months after galcanezumab treatment), 1 month after switching, and 4 months later are 6.9 (p = 0.002), 7.9 (p < 0.001), and 6.2 (p = 0.008), respectively. Adverse reactions to the anti-CGRP mAbs
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Aimovig (erenumab-aooe) / Amgen, Novartis
    Reimbursement, US reimbursement, Journal, Medicaid:  Observational Analysis of the Costs Associated with Acute Treatment of Breakthrough Migraine Attacks in Medicaid Patients Using Preventive Therapies. (Pubmed Central) -  Mar 9, 2023   
    However, the study shows little benefit from erenumab intensification, with similar effectiveness and worse tolerability than the standard dose. In consideration of the migraine-specific acute medications used in FFS Medicaid 2020, for patients using CGRP mAbs for prevention, medication costs may vary significantly with the number of breakthrough attacks treated per month and the type of migraine-specific acute therapy used.
  • ||||||||||  Opioid Use Among Migraine Patients Treated with Acute and Preventive Treatment () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_313;    
    The study assesses the real-world opioid utilization among migraine patients initiating on newer acute (ubrogepant, rimegepant, lasmiditan) and preventive (galcanezumab, erenumab, fremanezumab) migraine therapies and on standard of care (triptans). These findings suggest continued opioid use among migraine patients treated with both newer acute and preventive therapies and standard of care, highlighting the potential unmet pain management need for these patients.
  • ||||||||||  Journal:  Safety profile of monoclonal antibodies targeting the calcitonin gene-related peptide system in pregnancy: Updated analysis in VigiBase (Pubmed Central) -  Mar 1, 2023   
    Considering limitations of single studies, different populations such as episodic and chronic migraine, and the absence of head-to-head trials, all novel treatments decreased mean monthly migraine and headache days, and showed higher 50%, 75% and 100% responder rates than placebo.Trial registration: PROSPERO registration: CRD42022310579. This updated safety analysis on erenumab, galcanezumab, fremanezumab and eptinezumab in pregnancy showed no signals of foeto-maternal toxicity according to VigiBase
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Trial completion date, Trial primary completion date:  OASIS (CM): Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (clinicaltrials.gov) -  Feb 16, 2023   
    P3,  N=286, Recruiting, 
    Our results may encourage physicians in Japan to consider patient preferences when recommending migraine preventive treatments. Trial completion date: Jan 2027 --> Jun 2027 | Trial primary completion date: Aug 2024 --> Jun 2026
  • ||||||||||  Vyepti (eptinezumab-jjmr) / Teva, Lundbeck
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, HEOR, Real-world evidence, Real-world effectiveness, Real-world:  EVEC: Real World Effectiveness of Eptinezumab in Participants With Migraine (clinicaltrials.gov) -  Feb 8, 2023   
    P4,  N=32, Active, not recruiting, 
    Individualized approaches using a combination of new substances with oral prophylactic drugs or botulinum toxin A, switching between new drugs, and adjusting treatment duration could enhance excellence in practice. Recruiting --> Active, not recruiting | N=200 --> 32 | Trial completion date: Dec 2023 --> Apr 2023 | Trial primary completion date: Oct 2023 --> Mar 2023
  • ||||||||||  Chantix (varenicline) / Pfizer, Aimovig (erenumab-aooe) / Amgen, Novartis
    Journal:  The Relative Value of Anti-Obesity Medications Compared to Similar Therapies. (Pubmed Central) -  Feb 3, 2023   
    However, AOMs have limited formulary coverage. Improved coverage of AOMs may increase access to these treatments and may help address the clinical and economic burden associated with obesity and its comorbidities.
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Journal:  Switching OnabotulinumtoxinA to Monoclonal Anti-CGRP Antibodies in Drug-Resistant Chronic Migraine. (Pubmed Central) -  Jan 20, 2023   
    Switching to an anti-CGRP mAb appears to be a viable option in patients with insufficient response after the first 2 cycles with BTX-A. The appropriate variables, cut-offs, and timing to define ineffectiveness and the best time to switch or combine therapies for difficult-to-treat CM need to be investigated further.
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Biomarker, Trial completion:  INTERROGATE: Biomarker and Genetic Predictors of Erenumab Treatment Response (clinicaltrials.gov) -  Jan 19, 2023   
    P4,  N=1406, Completed, 
    The appropriate variables, cut-offs, and timing to define ineffectiveness and the best time to switch or combine therapies for difficult-to-treat CM need to be investigated further. Active, not recruiting --> Completed
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE) (clinicaltrials.gov) -  Jan 17, 2023   
    P2,  N=5, Terminated, 
    Active, not recruiting --> Completed N=60 --> 5 | Trial completion date: Apr 2025 --> Jan 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2024 --> Jan 2023; Low enrollment rate
  • ||||||||||  Review, Journal:  Headache: Treatment update. (Pubmed Central) -  Jan 14, 2023   
    Lasmiditan and the gepants are a good option for patients with moderate-severe migraine attacks who cannot use triptans due variously to poor tolerability, or cardio- or cerebrovascular disease. For practical purposes, the new anti-CGRP monoclonal antibodies are best reserved for patients who have failed to have efficacy or had intolerable side effects from multiple traditional oral preventives.
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Erenumab For Treatment of Hemicrania Continua (clinicaltrials.gov) -  Jan 10, 2023   
    P2,  N=2, Terminated, 
    More studies specifically evaluating medication tolerability in PTH are needed. N=20 --> 2 | Trial completion date: Aug 2023 --> Apr 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2023 --> Apr 2022; difficulty with recruitment
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Journal:  OnabotulinumtoxinA Add-On to Monoclonal Anti-CGRP Antibodies in Treatment-Refractory Chronic Migraine. (Pubmed Central) -  Dec 23, 2022   
    In the majority of cases (n = 14), dual targeting proved effective and was associated with clinically meaningful improvement in all efficacy variables; 50% response rates (also disability and QOL outcomes) coupled with favorable safety/tolerability. Our results advocate in favor of the view that dual therapy is effective and should be considered in difficult-to-treat CM patients who have failed all available monotherapies.