Ajovy (fremanezumab-vfrm) / Teva 
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 7 Diseases   13 Trials   13 Trials   1459 News 


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  • ||||||||||  Ajovy (fremanezumab) / Otsuka, Teva
    No  (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_3977;    
    Quarterly dosing results showed similar trends. Conclusions Over monthly dosing cycles of fremanezumab, no increases in migraine-related HCRU and acute medication use were seen, representing no evidence of wearing-off with fremanezumab and confirming post-hoc findings.
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Synergism of Anti-CGRP Monoclonal Antibodies and OnabotulinumtoxinA in the Treatment of Migraine (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_3479;    
    The reduction from the monotherapies were significantly different from the dual therapy (p>0.0001). Conclusions Combination therapy of anti-CGRP monoclonal antibodies and onabotulinumtoxinA may be more efficacious than monotherapy, possibly due to their synergistic mechanisms of action.
  • ||||||||||  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
  • ||||||||||  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
  • ||||||||||  Ajovy (fremanezumab) / Otsuka, Teva
    Review, Journal:  Review of Tolerability of Fremanezumab for Episodic and Chronic Migraine. (Pubmed Central) -  Feb 27, 2023   
    Treatment-related adverse reactions did not differ significantly compared to placebo and dropout rates were minimal. The most commonly observed treatment-related adverse reaction was mild-to-moderate injection site reaction, described as erythema, pain, induration, or swelling at the injection site.
  • ||||||||||  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
  • ||||||||||  Ajovy (fremanezumab) / Otsuka, Teva
    Trial completion date, Trial primary completion date:  Fremanezumab, Migraine and Sleep (clinicaltrials.gov) -  Feb 2, 2023   
    P4,  N=100, Recruiting, 
    The potential mechanism of alopecia with drugs targeting calcitonin gene-related peptide or its receptor possibly includes disruptions in the microvascular circulation and other homeostatic mechanisms. Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Jul 2022 --> Jul 2024
  • ||||||||||  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.
  • ||||||||||  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.
  • ||||||||||  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.
  • ||||||||||  Ajovy (fremanezumab) / Otsuka, Teva
    Trial completion date, Trial primary completion date:  A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age (clinicaltrials.gov) -  Dec 9, 2022   
    P3,  N=418, Recruiting, 
    The authors state that real-world surveys have shown constipation to be a "major adverse event" reported in "more than 50% of patients treated with erenumab, fremanezumab or galcanezumab." As described in the current commentary, the limited data from the cited references in the review article by Holzer and Holzer-Petsche do not support that statement. Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
  • ||||||||||  Review, Journal:  Effectiveness and Safety of Chronic Migraine Preventive Treatments: A Systematic Literature Review. (Pubmed Central) -  Nov 24, 2022   
    Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026 While substantial real-world evidence supports the long-term effectiveness and safety of onabotulinumtoxinA, real-world data on other preventive treatments of CM are currently limited to short term effectiveness due to their more recent approvals.
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Journal:  Effectiveness of anti-CGRP monoclonal antibodies on central symptoms of migraine. (Pubmed Central) -  Nov 8, 2022   
    These results aid in supporting the safety profile of CGRP mAbs in the real-world setting and may provide clinicians and patients with additional insight when considering migraine preventive treatments. Anti-calcitonin gene-related peptide antibodies seems to significantly impact brain functions of migraineurs, preventing not only migraine headache but also its anticipatory and accompanying symptoms.
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Journal:  Predictors of response to anti-CGRP monoclonal antibodies: a 24-week, multicenter, prospective study on 864 migraine patients. (Pubmed Central) -  Nov 2, 2022   
    A critical evaluation of headache characteristics indicating peripheral or central sensitization may help in predicting responsiveness to antiCGRP mAbs in HFEM and CM. A more precise pain profiling may represent a steppingstone for a mechanism-based approach and personalized treatment of migraine with compounds targeting specific molecular mechanisms.
  • ||||||||||  Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Retrospective data, Journal:  Blood Pressure in Migraine Patients Treated With Monoclonal Anti-CGRP (receptor) Antibodies: A Prospective Follow-up Study. (Pubmed Central) -  Oct 27, 2022   
    The majority of patients remained within the normal BP limits, but some patients required antihypertensive treatment. Physicians should be aware that people with migraine may be at risk of developing hypertension when treated with anti-CGRP (receptor) antibodies, and this should be added to (inter)national treatment guidelines.
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
    Enrollment open:  Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study (clinicaltrials.gov) -  Oct 19, 2022   
    P=N/A,  N=1500, Recruiting, 
    Additional long-term data is needed to further evaluate sustained efficacy, predictors of treatment response, and adverse events. Not yet recruiting --> Recruiting