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- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Real-world impact of AJOVY use on clinical outcomes among migraine patients with comorbid depression, anxiety or hypertension () - Jun 4, 2021 - Abstract #AHS2021AHS_268;
With AJOVY treatment in a real-world setting, there was a statistically significant decrease in anti-depressant prescription use for patients with comorbid depression, as in anxiolytic prescription use for patients with comorbid anxiety. Among patients with comorbid HTN, non-significant decreases were observed in mean SBP and DBP levels with AJOVY treatment.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Real-world migraine-related health care resource utilization and costs for patients initiating fremanezumab: A US retrospective claims analysis () - Jun 4, 2021 - Abstract #AHS2021AHS_267;
Among patients with comorbid HTN, non-significant decreases were observed in mean SBP and DBP levels with AJOVY treatment. Within the first 6 months after fremanezumab initiation, fremanezumab treatment is associated with statistically significant reductions in migraine-related inpatient, ED, and outpatient visits; acute medication prescriptions; and outpatient and acute medication costs.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Real-world patient characteristics, acute medication use, and treatment patterns for patients initiating fremanezumab treatment: A US retrospective claims analysis () - Jun 4, 2021 - Abstract #AHS2021AHS_266;
Within the first 6 months after fremanezumab initiation, fremanezumab treatment is associated with statistically significant reductions in migraine-related inpatient, ED, and outpatient visits; acute medication prescriptions; and outpatient and acute medication costs. Within the first 12 months of treatment initiation, fremanezumab treatment is associated with statistically significant reductions in acute medication claims, including reductions in opioid and triptan claims, and very high levels of treatment adherence.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Real-world data on quarterly and monthly fremanezumab for reducing migraine days and headache days in US adult patients with migraine: Results from a physician chart review study () - Jun 4, 2021 - Abstract #AHS2021AHS_265;
Within the first 12 months of treatment initiation, fremanezumab treatment is associated with statistically significant reductions in acute medication claims, including reductions in opioid and triptan claims, and very high levels of treatment adherence. Both quarterly and monthly fremanezumab resulted in clinically meaningful reductions in both MMD and MHD that increased over a period of 6 months in a real-world setting, with no relevant differences in reduction of MMD or MHD between quarterly and monthly dosing regimens.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Real-world data on reductions in migraine and headache days with fremanezumab treatment for US patients with chronic and episodic migraine: Results from a physician chart review study () - Jun 4, 2021 - Abstract #AHS2021AHS_264;
Fremanezumab treatment resulted in clinically meaningful reductions in both MMD and MHD for CM and EM patients that increased over a period of 6 months in a US real-world setting. Encore: previously submitted to AAN 2021, April 1722, 2021, Virtual Annual Meeting
- Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Adherence and persistence associated with calcitonin gene-related peptide monoclonal antibodies compared to non-calcitonin gene-related peptide monoclonal antibodies treatments for prevention of migraine () - Jun 4, 2021 - Abstract #AHS2021AHS_260;
Adults with 1 claim (first claim=index) for a CGRP mAb (galcanezumab, erenumab, fremanezumab) or non-CGRP mAb treatment (antidepressants, beta-blockers, anticonvulsants, or neurotoxin) between May 1, 2018 and June 30, 2019 with continuous enrollment in medical and pharmacy benefits for 12 months pre- and 6 months post-index were included. Patients on CGRP mAbs were more likely to be adherent and persistent compared to patients on non-CGRP mAbs.
- Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Switching associated with initiation of calcitonin gene-related peptide monoclonal antibodies versus non-calcitonin gene-related peptide monoclonal antibodies treatments for prevention of migraine () - Jun 4, 2021 - Abstract #AHS2021AHS_255;
CGRP mAb initiators were less likely to discontinue therapy over the 6-month post-index period compared to non-CGRP mAb initiators; however, out of those that discontinued, CGRP mAb initiators were more likely to switch compared to those on non-CGRP mAbs. The average time to switch was longer for those initiating CGRP mAbs compared to non-CGRP mAb initiators.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Single center experience of mAbs-CGRP use for migraine prevention () - Jun 4, 2021 - Abstract #AHS2021AHS_254;
Reasons for stopping included medication failure, adverse effects, and insurance difficulties. Combined use of mAb and OnabotulinumbtoxinA seemed to be a safe and efficacious treatment of migraine.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Safety evaluation of fremanezumab in nonclinical developmental and reproductive toxicology (DART) studies in rats and rabbits () - Jun 4, 2021 - Abstract #AHS2021AHS_164;
The nonclinical developmental and reproductive toxicology data in total indicate no safety signal following repeated administration of fremanezumab to rats and rabbits. Adequate margins of exposure were calculated in both rats and rabbits compared to the recommended clinical dose levels of 225mg monthly or 675mg quarterly, both approved for the prevention of migraine in adults.
- ||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical, P1 data, P3 data, PK/PD data, Journal: Scaling Approaches for Pediatric Dose Selection: The Fremanezumab (AJOVY) Journey to Select a Phase 3 Dose Using Pharmacokinetic Data from a Phase 1 Study. (Pubmed Central) - Jun 3, 2021
A thorough evaluation was conducted to further characterize the population PK of fremanezumab and assess the predictive performance of the adult population PK model when applied to the Phase 1 pediatric data, the predictive performance of alternative pediatric population PK models, and the predictive performance of the selected pediatric population PK model via a noncompartmental-based approach. This latter comparison to noncompartmental results provided additional evidence that the pediatric population PK model predicts the observed data well and supports the 120 mg monthly dose in patients weighing <45 kg.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Pooled analysis of changes in heart rate and blood pressure with fremanezumab in migraine patients (CBW Room) - May 30, 2021 - Abstract #EAN2021EAN_1973;
This latter comparison to noncompartmental results provided additional evidence that the pediatric population PK model predicts the observed data well and supports the 120 mg monthly dose in patients weighing <45 kg. This pooled analysis showed that, at the end of 12 weeks of DB treatment, fremanezumab treatment resulted in minimal increases in HR and decreases in SBP and DBP from baseline that were not clinically significant and were comparable to those observed in the placebo group.
- verapamil / Generic mfg., sumatriptan succinate / Generic mfg.
[VIRTUAL] Off-label use of CGRP monoclonal antibodies in patients with chronic cluster headache (Room Budapest) - May 30, 2021 - Abstract #EAN2021EAN_1457;
CGRP monoclonal antibodies may be effective in patients with chronic cluster headache. However, clinical trials are needed to prove efficacy on a large group of patients.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] When chronic migraine remains refractory: can anti-CGRP monoclonal antibodies be combined with onabotulinumtoxinA? (Room Budapest) - May 30, 2021 - Abstract #EAN2021EAN_1441;
There is still no literature supporting the benefit of combining onabotA and anti-CGRP mAbs in chronic migraine. They have independent mechanisms of action, good safety profile with no superimposed risk, and, most of all, good outcomes in headache trials.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Pooled analysis of the timing and location of injection-site adverse events with fremanezumab in patients with migraine (Room Budapest) - May 30, 2021 - Abstract #EAN2021EAN_1435;
They have independent mechanisms of action, good safety profile with no superimposed risk, and, most of all, good outcomes in headache trials. In this pooled analysis including >1,800 patients receiving fremanezumab, the most common AEs were injection-site AEs, which occurred most frequently in the limb and during the first month of treatment.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Pooled analysis of efficacy of fremanezumab for reducing disability and acute medication overuse in migraine patients (Room Berlin) - May 30, 2021 - Abstract #EAN2021EAN_1394;
In this pooled analysis including >1,800 patients receiving fremanezumab, the most common AEs were injection-site AEs, which occurred most frequently in the limb and during the first month of treatment. Treatment with fremanezumab was effective and resulted in significant reductions in disability and overuse of acute migraine-specific abortive medications, demonstrating the benefits of fremanezumab in those with overuse of acute migraine-specific medications.
- Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] NMA of migraine day reductions with CGRP pathway-targeting mAbs in migraine patients with multiple preventive failures (Room Berlin) - May 30, 2021 - Abstract #EAN2021EAN_1393;
Fremanezumab, galcanezumab, and erenumab showed statistically significant reductions in MMD versus placebo in migraine patients with multiple prior preventive failures. No statistically significant differences were noted for fremanezumab versus erenumab or galcanezumab.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Real-world evidence for chronic migraine control in patients receiving treatment with CGRP mAbs and onabotulinumtoxinA (Room Berlin) - May 30, 2021 - Abstract #EAN2021EAN_1390;
This real-world study of CM patients demonstrated clinically meaningful benefits with onabotulinumtoxinA alone and additive benefits after adding CGRP mAb with no new safety signals. More real- world studies and controlled trials are needed to further quantify potential benefits of this multimodal treatment paradigm.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] 6-month efficacy of fremanezumab in migraine patients with inadequate response to ≥3 preventive medication classes (Room Budapest) - May 30, 2021 - Abstract #EAN2021EAN_824;
More real- world studies and controlled trials are needed to further quantify potential benefits of this multimodal treatment paradigm. Fremanezumab demonstrated sustained efficacy and improvements in disability over ≤6 months in migraine patients with inadequate response to ≥3 preventive medication classes.
- || Review, Journal: Pharmacological treatment of migraine: CGRP and 5-HT beyond the triptans. (Pubmed Central) - May 28, 2021
Although all of these drugs seem highly promising for migraine treatment, their safety should be investigated in the long-term. Moreover, the exact mechanism(s) of action of these drugs need to be elucidated further, to increase both safety and efficacy and to increase the number of responders to the different treatments, so that all migraine patients can satisfactorily be treated.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Real-world evidence for control of patients with chronic migraine who received calcitonin gene-related peptide monoclonal antibody therapy added to OnabotulinumtoxinA treatment () - May 16, 2021 - Abstract #AHS2021AHS_111;
Combination therapy was well tolerated with no new safety signals identified. More real-world studies and controlled trials are needed to further quantify potential benefits of this multimodal treatment paradigm.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] A phase 2 study of fremanezumab as a treatment for posttraumatic headache in adult patients () - May 16, 2021 - Abstract #AHS2021AHS_108;
This study did not demonstrate numerical or statistical differences between fremanezumab and placebo treatment for any of the efficacy endpoints in patients with an established pattern of PTH. Despite being administered at a higher dose than labeled for migraine, safety data for fremanezumab 675 mg monthly was comparable to placebo administration and consistent with the known safety profile of fremanezumab.
- | Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open: Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial (clinicaltrials.gov) - May 2, 2021
P=N/A, N=182, Recruiting, Sponsor: Universidad de Zaragoza
Despite being administered at a higher dose than labeled for migraine, safety data for fremanezumab 675 mg monthly was comparable to placebo administration and consistent with the known safety profile of fremanezumab. Not yet recruiting --> Recruiting
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] A Pooled Analysis of Phase 3 Studies of Fremanezumab for the Preventive Treatment of Chronic Migraine in Patients With Comorbid Depression () - May 2, 2021 - Abstract #APA2021APA_1023;
In patients with CM and comorbid depression, fremanezumab treatment resulted in statistically significant reductions in the number of migraine days and headache days of at least moderate severity versus placebo at all follow- up time points. switching to or adding another treatment for
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] UNITE Randomized, Placebo-Controlled Phase 4 Study Protocol: Fremanezumab for Preventive Migraine Treatment in Patients With Major Depressive Disorder () - May 2, 2021 - Abstract #APA2021APA_1008;
switching to or adding another treatment for By assessing a range of efficacy outcomes, patient-reported outcomes, and tolerability in patients with MDD, UNITE will provide valuable evidence for the efficacy and tolerability of fremanezumab in patients with migraine and comorbid MDD.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Long-Term Efficacy of Fremanezumab in Migraine Patients With Comorbid Depression and Inadequate Response to 2-4 Migraine Preventive Medication Classes () - May 2, 2021 - Abstract #APA2021APA_970;
By assessing a range of efficacy outcomes, patient-reported outcomes, and tolerability in patients with MDD, UNITE will provide valuable evidence for the efficacy and tolerability of fremanezumab in patients with migraine and comorbid MDD. Fremanezumab demonstrated sustained effectiveness, based on reductions in MMDs and MHDs, as well as improvements in depressive symptom levels, in pts with migraine, moderate to severe depression, and inadequate response to 2-4 migraine preventive medication classes.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Fremanezumab Treatment Reduced Monthly Migraine Days and Anxiety or Depression Symptoms for Migraine Patients With Comorbid MDD or GAD in the US () - May 2, 2021 - Abstract #APA2021APA_948;
In this US real-world study, fremanezumab treatment was associated with clinically meaningful reductions in MMD that increased over 6 months for patients with MDD or GAD at baseline. Almost half of all patients with these psychiatric comorbidities showed improved symptoms of MDD and GAD with fremanezumab treatment.
- ||| Journal, Adverse events: Cost of fremanezumab, erenumab, galcanezumab and onabotulinumtoxinA associated adverse events, for migraine prophylaxis in Spain. (Pubmed Central) - Apr 29, 2021
Almost half of all patients with these psychiatric comorbidities showed improved symptoms of MDD and GAD with fremanezumab treatment. The different safety profile of treatment with fremanezumab, compared to erenumab, galcanezumab, and onabotulinumtoxinA, would generate savings in health-care resources in all the scenarios considered.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Industry Therapeutic Update from Teva: Spotlight on AJOVY: The long-acting anti-CGRP injection with the option of dosing only 4 times a year () - Apr 25, 2021 - Abstract #AAN2021AAN_3583;
- | TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Preclinical, Journal: Fremanezumab and its isotype slow propagation rate and shorten cortical recovery period but do not prevent occurrence of cortical spreading depression in rats with compromised blood brain barrier. (Pubmed Central) - Apr 23, 2021
Similarly, we cannot conclude that CGRP is involved in the propagation velocity or the neuronal silencing period (also called cortical recovery period) that follows the CSD because similar effects were observed when the isotype was used. These finding call for caution with interpretations of studies that claim to show direct CNS effects of anti-CGRP-mAbs.
- |||| Ajovy (fremanezumab) / Otsuka, Teva
Trial completion date, Trial primary completion date: A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents (clinicaltrials.gov) - Apr 22, 2021
P3, N=550, Recruiting, Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
These finding call for caution with interpretations of studies that claim to show direct CNS effects of anti-CGRP-mAbs. Trial completion date: May 2024 --> Jan 2025 | Trial primary completion date: May 2023 --> Aug 2024
- |||| Ajovy (fremanezumab-vfrm) / Teva
Trial completion date, Trial primary completion date: A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age (clinicaltrials.gov) - Apr 22, 2021
P3, N=288, Recruiting, Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Trial completion date: May 2024 --> Jan 2025 | Trial primary completion date: May 2023 --> Aug 2024 Trial completion date: Apr 2022 --> Dec 2022 | Trial primary completion date: Apr 2022 --> Dec 2022
- || TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Clinical Trial,Phase III, Journal: Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial. (Pubmed Central) - Apr 22, 2021
P3
Trial completion date: Apr 2022 --> Dec 2022 | Trial primary completion date: Apr 2022 --> Dec 2022 Monthly and quarterly fremanezumab significantly reduced the monthly average number of migraine days versus placebo regardless of country and continent (North America versus Europe) in migraine patients with documented inadequate response to 2 to 4 migraine preventive medication classes.
- || Botox (onabotulinumtoxin A) / GSK, AbbVie
Retrospective data, Review, Journal, HEOR, Real-world evidence: Real-World Evidence for Control of Chronic Migraine Patients Receiving CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA: A Retrospective Chart Review. (Pubmed Central) - Apr 22, 2021
In this real-world study, combination treatment with onabotulinumtoxinA and CGRP mAbs was well tolerated, with no new safety signals identified, and was associated with additional clinically meaningful benefits. More real-world and controlled trials should be considered to further assess safety and potential benefits of combination treatment.
- || Clinical, Retrospective data, Review, Journal: Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis. (Pubmed Central) - Apr 21, 2021
Most drugs performed similarly and were superior to placebo in most of our analyses. Further head-to-head research on different types of CGRP monoclonal antibodies is necessary to validate the present findings.
- | Aimovig (erenumab) / Amgen, Novartis
Journal: In brief: Hypertension with erenumab (Aimovig). (Pubmed Central) - Apr 20, 2021
Further head-to-head research on different types of CGRP monoclonal antibodies is necessary to validate the present findings. No abstract available
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Fremanezumab treatment results in real-world improvements in migraine pain intensity and symptoms () - Apr 17, 2021 - Abstract #AMCP2021AMCP_328;
No abstract available In this real-world observational study, fremanezumab treatment was associated with significant reductions in MPI and an improvement in headache frequency and symptoms in majority of the patients.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Fremanezumab treatment reduces headache frequency and health care resource utilization in a real-world setting () - Apr 17, 2021 - Abstract #AMCP2021AMCP_326;
In this real-world observational study, fremanezumab treatment was associated with significant reductions in MPI and an improvement in headache frequency and symptoms in majority of the patients. In this real-world study, fremanezumab treatment was associated with significant reductions in headache frequency and HCRU in patients with migraine.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Real-world evidence for control of patients with chronic migraine who received calcitonin generelated peptide (CGRP) monoclonal antibody therapy added to onabotulinumtoxinA treatment () - Apr 17, 2021 - Abstract #AMCP2021AMCP_320;
Combination therapy was well tolerated with no new safety signals identified. More real-world studies and controlled trials are needed to further quantify potential benefits of this multimodal treatment paradigm.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Scenario Analyses on Major Impactful and Uncertain Inputs of the Cost-Effectiveness Model of Fremanezumab From a Healthcare System Perspective in England () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1094;
P3
Without consideration of positive stopping, the ICER increased to £17,059/QALY versus BSC and £25,033/QALY versus onabotulintumtoxinA in CM; with an ICER of £20,761 in EM. CONCLUSIONS Under all analyses conducted fremanezumab was cost effective, which shows that fremanezumab is cost-effective in England under a variety of plausible modelling scenarios as considered by NICE.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] The Cost-Effectiveness of Fremanezumab in Patients with Migraine Who Have Failed Two or More Previous Migraine Preventive Therapies From a UK Healthcare System Perspective () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1091;
P3
Best supportive care (acute migraine treatment only, modelled using FOCUS placebo data) was the comparator in this analysis, as insufficient data were available to allow a network-meta analysis comparison to onabotulinumtoxinA. Fremanezumab has been found to be cost-effective after previous inadequate response to two or more previous migraine preventive treatments.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Cost-effectiveness of Fremanezumab from a Societal Perspective in England () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1088;
P3
Fremanezumab is cost-effective under a healthcare perspective (as used in many HTAs across Europe). When a societal impact of migraine is considered, the cost-effectiveness of fremanezumab can be even more clearly demonstrated, especially in CM.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] The Cost-Effectiveness of Fremanezumab in Patients With Migraine and Previous Inadequate Response to OnabotulinumtoxinA From a UK Healthcare System Perspective () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1085;
P3
Fremanezumab is cost-effective in UK patients who have previously failed onabotulinumtoxinA therapy. This demonstrates that fremanezumab is a cost-effective treatment option for the large population of CM patients that have had an inadequate treatment response to onabotulinumtoxinA.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Cost-Effectiveness of Fremanezumab for the Treatment of Migraine in England From a Healthcare System Perspective () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1077;
P3
Probabilistic analyses resulted in fremanezumab being cost-effective at a willingness-to-pay threshold of £30,000/QALY. CONCLUSIONS Using the England NHS perspective, this study concluded that fremanezumab is a cost-effective treatment when compared with BSC and onabotulinumtoxinA.
- Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Improvements in Migraine-specific Quality of Life Questionnaire (MSQ) Domain Scores with Fremanezumab and Galcanezumab in Patients with Multiple Prior Migraine Preventive Treatment Failures- A Network Meta-analysis () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1068;
CONCLUSIONS Both fremanezumab and galanezumab showed statistically significant and clinically meaningful increases in MSQ scores versus placebo in migraine patients with multiple prior preventive failures. Across all 3 MSQ domains, no statistically significant differences were noted between fremanezumab and galcanezumab.
- [VIRTUAL] Withdrawn: A Framework Assessing the Impact of Patient-Centred Outcome Evidence in Regulatory Approvals () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_207;
Despite FDA guidelines on PCO evidence, it appears a consistent, systematic and successful approach to inclusion is yet to be established. Future research on a larger dataset may further elucidate FDA and EMA requirements.
- TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] FREMANEZUMAB TREATMENT RESULTS IN REAL-WORLD REDUCTIONS IN MONTHLY MIGRAINE AND HEADACHE DAYS IN PATIENTS HAVING DIFFERENT NUMBERS OF PRIOR MIGRAINE PREVENTIVE TREATMENT FAILURES () - Apr 11, 2021 - Abstract #AMCP2021AMCP_119;
Future research on a larger dataset may further elucidate FDA and EMA requirements. In this US real-world study, fremanezumab treatment resulted in similar and clinically meaningful reductions in MMD and MHD that increased over 6 months regardless of the number of prior migraine preventive treatment failures (<2 and ≥2 failures).
- ||| TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
#clusterheadache updates by @petergoadsby #HCNE2021Stowe. Need to understand the biology of TAC turnoff, NTG study attempting to dissect phenotype, episodic w better response to fremanezumab &gammacore. New RCT prednisone for short term Rx cluster attack: https://t.co/1ZUkR91Js0 (Twitter) - Apr 9, 2021
- || Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo
Clinical, Review, Journal: The Role of Galcanezumab in Migraine Prevention: Existing Data and Future Directions. (Pubmed Central) - Apr 7, 2021
Furthermore, its safety profile, especially its potential association with an increased cardiovascular risk, needs to be established through long-term, real-world data. This review aims to give an overview of its pharmacological properties as well as to report and discuss data from clinical trials and its potential place in headache therapeutics.
- | Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo
Journal: Galcanezumab for the prevention of Cluster Headache. (Pubmed Central) - Mar 24, 2021
Inefficacy of galcanezumab in chronic CH as well as the inefficacy of another monoclonal antibody against CGRP (fremanezumab) in both episodic and chronic CH question the scalability of the drug in CH management. Further, studies comparing galcanezumab to the current standard treatments are highly desirable.
- || Ajovy (fremanezumab) / Otsuka, Teva
I do & I’m on Ajovy. It has reduced them by about 70% so I’m down to 4 or so a month. I’ll take it! (Twitter) - Mar 21, 2021