Ajovy (fremanezumab-vfrm) / Otsuka, Teva - LARVOL DELTA

Patient Preferences for Self-Injectable Preventive Treatment for Migraine: A Multi-country Discrete Choice Experiment. (PubMed, Neurol Ther) - "Participants tended to prefer self-injectable CGRP mAb autoinjectors over non-CGRP oral preventive medications for migraine. Preferences among autoinjectors were driven by injection duration, auto-retractability of needle removal, storage requirements, and autoinjector base and pinching requirements."

Journal • CNS Disorders • Epilepsy • Migraine • Pain

Ajovy: PDUFA action date for pediatric migraine in Aug 2025 (Teva) - Q2 2025 Results

PDUFA • CNS Disorders • Migraine • Pain

Teva’s Innovative Portfolio Fuels 10th Consecutive Quarter of Growth in Q2 2025; Increases 2025 Revenue Outlook for Key Innovative Products and EPS, and Reaffirms All Other Components (GlobeNewswire) - "AJOVY revenues in our United States segment in the second quarter of 2025 were $63 million, an increase of 53% compared to the second quarter of 2024, mainly due to an increase in sales allowance due to a non-recurring item in the second quarter of 2024 and growth in volume in the second quarter of 2025....AUSTEDO revenues in our United States segment in the second quarter of 2025 were $495 million, an increase of 22%, compared to $407 million in the second quarter of 2024....UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the second quarter of 2025 were $54 million, an increase of 120% compared to the second quarter of 2024, mainly due to growth in volume....COPAXONE revenues in our United States segment in the second quarter of 2025 were $62 million, a decrease of 23% compared to the second quarter of 2024, mainly due to market share erosion and competition."

Sales • Huntington's Disease • Migraine • Multiple Sclerosis • Schizophrenia

The state of insurance coverage of calcitonin gene-related peptide-targeted medications and its impact on the implementation of the American Headache Society's 2024 consensus statement: An interrupted time-series analysis. (PubMed, Headache) - "Ten months after the American Headache Society's March 2024 consensus statement made the CGRP-targeted medications first-line for the prevention of migraine, insurance companies have had incomplete compliance with the recommendations, potentially limiting the full impact of the AHS' consensus statement on the utilization of the CGRP-targeted therapies."

Journal • Reimbursement • US reimbursement • CNS Disorders • Migraine • Pain

Tolerability of switch from erenumab to fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, real-world, observational study. (PubMed, J Headache Pain) - No abstract available

Journal • Observational data • Real-world evidence • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

CACS: Clinical advantages of cGRPi switch, a retrospective observational study (AHS 2025) - "The advent of calcitonin gene-related peptide (CGRP) antagonists—such as erenumab (a receptor blocker) and galcanezumab, fremanezumab, eptinezumab (ligand blockers)—offers a novel targeted approach. CGRP antagonists demonstrate efficacy in managing migraines but require better data collection and patient monitoring to optimize outcomes. Continuous monitoring, personalized treatment strategies, and further research are necessary to improve clinical decision-making and healthcare efficiency. FIGURE 1."

Observational data • Retrospective data • CNS Disorders • Migraine • Pain

Retention rates across clinical trials of anti-CGRP monoclonal antibodies for migraine prevention (AHS 2025) - "Similar trials with other anti-CGRP mAbs relative to PREVAIL (ie, long-term [≥48-week] trials in chronic migraine [CM]) were included: REGAIN (galcanezumab), phase 2 trial (erenumab) and HALO CM (fremanezumab). Eptinezumab demonstrated high, long-term retention rates for preventive treatment in participants with CM and in those with migraine for whom 2-4 prior migraine preventive treatments have failed. These findings suggest a high level of participant satisfaction with continued treatment of eptinezumab."

Clinical • CNS Disorders • Migraine • Pain

Real world evidence for risk-averse behavior in the prescribing of calcitonin gene-related peptide monoclonal antibodies by headache specialists for the prevention of migraine: A retrospective, cohort study (AHS 2025) - "In an open-label extension study of erenumab 2/383 (0.7%) patients reported a cardiovascular event and no patients reported a cerebrovascular event in a 5 year follow up period (Ashina 2019). Other studies evaluating CGRP mAbs, such as galcanezumab and fremanezumab, are reassuring but largely limited to 1–2 year follow up studies (Yang 2025)...Patients were matched for sex, age, high cholesterol (denoted by an ICD-10 code of E78), diabetes mellitus (ICD-10 codes E10 and E11), onabotulinumtoxin A prescriptions, and duration in database... In our cohort of patients, individuals who received CGRP mAbs were overall less likely to be subsequently diagnosed with HTN, CVA, MI, or constipation, with the lowest rates in the CGRP mAb group prescribed by a headache provider and higher in in the group prescribed a CGRP mAb by a non-headache neurologist. These results suggest that headache providers may be more cognizant of the potential risks and complications of these medications...."

HEOR • Real-world • Real-world evidence • Retrospective data • CNS Disorders • Migraine • Pain

Dual calcitonin gene-related peptide antagonists for chronic migraine prevention (AHS 2025) - "These medications are divided into monoclonal antibodies, "-mAbs" (erenumab, fremanezumab, galcanezumab, and eptinezumab) and small molecule "-gepants" (rimegepant and atogepant)...Common prior or concurrent non-CGRP antagonist migraine preventive medications included topiramate (84%), tricyclic antidepressants (76%), and onabotulinumtoxinA (73%)... In our small sample, dual preventive CGRP antagonist use was well-tolerated and may be considered for patients with chronic migraine who are resistant to usual treatment. However, larger studies are needed to confirm the safety and efficacy of this approach."

CNS Disorders • Depression • Migraine • Mood Disorders • Pain • Psychiatry

Longitudinal effects of CGRP pathway-targeting migraine therapies on blood pressure and body mass index: A 12-month retrospective analysis (AHS 2025) - " Using data from electronic health records at Jefferson Headache Center, we conducted a retrospective study of adult patients with naïve use of either gepants (atogepant, rimegepant) or CGRP mAbs (erenumab, fremanezumab, galcanezumab) for migraine prevention. These findings suggest that most CGRP pathway-targeting migraine medications have negligible effects on monthly changes in BP over one year. These BP differences were small in magnitude and of unclear clinical significance. Study limitations include the unbalanced distribution of medications and potential changes in antihypertensive medication regimens during the one-year study period that could not be fully captured in our model."

Retrospective data • CNS Disorders • Migraine • Pain

Long-term persistence of patients with chronic migraine switching to onabotulinumtoxinA or a different calcitonin gene-related peptide monoclonal antibody (CGRP mAb) after initial CGRP mAb treatment (AHS 2025) - "This study included patients who had ≥1 claims of a CGRP mAb, then initiated another CGRP mAb (erenumab, fremanezumab, galacanezumab, eptinezumab) or onabotA for 12-24 months post-index. This retrospective, real-world study demonstrated that patients with CM who switched to onabotA treatment after an initial CGRP mAb were more likely to remain persistent on therapy for 12-24 months compared to patients with CM who switched to another CGRP mAb."

Clinical • CNS Disorders • Migraine • Pain

Real-world switch rates of injectable migraine preventive therapies in patients with chronic migraine (AHS 2025) - "The primary endpoint was treatment switching, defined by the occurrence of ≥1 claim for a different branded migraine preventive treatment (onabotA, CGRP mAb, or atogepant) in the 12 months following the index date... A total of 1869 patients met the study inclusion criteria, of which 723 initiated onabotA and 1146 initiated a CGRP mAb (303 erenumab, 308 fremanezumab, 517 galcanezumab, 18 eptinezumab) as their index therapy... Chronic migraine patients on a CGRP mAb were significantly more likely to switch to a different branded migraine preventive treatment within 12 months of treatment initiation compared to those on onabotA."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine • Pain

Effects of injectable calcitonin gene-related peptide-antagonists on migraine-associated cost burden (AHS 2025) - "To date, three subcutaneous injections have been approved: erenumab-aooe, fremanezumab-vfrm, and galcanezumab-gnlm. While limited by a small sample size, the results support continued prescribing of injectable CGRP antagonists to increase cost savings at this VA medical center. These medications were associated with significant reductions in as-needed visits, abortive medication refills, and patient-reported migraine days. These results highlight the clinical, economic, and humanistic benefits of prescribing injectable CGRP antagonists to patients for migraine prevention."

CNS Disorders • Migraine • Pain

Characteristics and eptinezumab infusion experience in participants in whom ≥1 prior preventive anti-CGRP treatment had failed: Interim results of an ongoing real-world study (AHS 2025) - "INFUSE includes adults ≥18 years of age with a diagnosis of migraine in whom ≥1 preventive a-CGRP treatment had failed (erenumab, fremanezumab, galcanezumab, atogepant, or rimegepant [prescribed every other day]). Results of this interim analysis of the INFUSE study indicate that individuals with migraine initiating eptinezumab treatment after ≥1 prior a-CGRP preventive treatment had failed typically have a long history of disease, severe migraine, and have cycled through three or more a-CGRP preventive treatments. The level of concern about initiating an IV treatment was low, and participants generally had a positive infusion experience."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine • Pain • Psychiatry

CGRP antibodies exacerbate stroke outcomes following blood-brain barrier opening (AHS 2025) - "Fremanezumab worsened stroke outcomes after BBB opening, suggesting potential adverse effects under conditions mimicking migraine aura. Long-term use of Fremanezumab in migraine patients, particularly those at risk for stroke, may increase the risk of worsened stroke outcomes. Further studies are needed to explore these vascular changes and their clinical implications."

CNS Disorders • Migraine • Pain

Treatment with fremanezumab attenuates the association between weather and headache in participants with episodic migraine: A post-hoc analysis of the HALO-EM and HALO-LTS studies (AHS 2025) - P3 | "A daily average temperature increase of 10 F was associated with an increased risk of AOH and NOH in this patient population from across the US. Fremanezumab treatment attenuated the association between a 10 F increase in temperature and AOH or NOH days, suggesting that fremanezumab may prevent temperature-triggered headaches in people with EM, especially over a prolonged treatment period. This association may reveal a novel pathway for headache treatments."

Retrospective data • CNS Disorders • Migraine • Pain • TRPM3

Investigating the role of fremanezumab in cortical spreading depression and migraine pathophysiology (AHS 2025) - "Our findings indicate that the therapeutic effects of Fremanezumab in migraine are predominantly mediated through peripheral mechanisms, even when the antibody transiently penetrates the cerebral cortex during BBB disruption. When BBB permeability is increased, circulating Fremanezumab gains access to the cortical region and binds to locally distributed CGRP. However, despite this binding interaction occurring during the BBB permeability window, Fremanezumab administration did not significantly modulate CSD parameters."

CNS Disorders • Depression • Migraine • Mood Disorders • Pain • Psychiatry

Burning mouth syndrome responsive to trial of fremanezumab: A case report (AHS 2025) - "Medications tried without improvement and/or discontinued due to adverse effects include nortriptyline, gabapentin, caffeine, zinc supplementation, alpha-lipoic acid, clonazepam, pregabalin, sertraline, valacyclovir, low-dose naltrexone, topical pilocarpine, and oxycodone. This case illustrates a novel application of CGRP targeting therapies in a patient with Burning Mouth Syndrome, which can be a difficult condition to treat either due to lack of efficacy or intolerability of medications. Furthermore, this case highlights the complexities of care when a beneficial treatment is finally identified but can not be obtained due to access to care. Although CGRP involvement in migraine pathophysiology and treatment is established, its role in other pain disorders, such as Burning Mouth Syndrome, has not yet been elucidated."

Case report • Clinical • CNS Disorders • Migraine • Pain

Efficacy and safety of fremanezumab for the preventive treatment of episodic migraine in children and adolescents: A phase 3, randomized, double-blind, placebo-controlled study (AHS 2025) - P3 | "These findings demonstrate the efficacy, safety, and tolerability of fremanezumab in children and adolescents with EM."

Clinical • P3 data • CNS Disorders • Migraine • Pain

Final Data from Teva’s PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY (fremanezumab) for the Prevention of Chronic and Episodic Migraine (Teva Press Release) - P=Obs | N=1,140 | PEARL (EUPAS35111) | "PEARL, a 24-month real-world observational study assessed the impact of fremanezumab for migraine prevention in 1,140 patients, predominantly female (87.25%) with 33.1% living with episodic migraine (EM), and 66.9% with chronic migraine (CM). The final study showed that over 66% of patients with EM and 51.6% with CM who had achieved the primary endpoint of a ≥50% reduction in Monthly Migraine Days (MMD) during the first 6 months of treatment benefited from sustained migraine prevention for over 24 months. Injection adherence rates remained high throughout (~90%) the study, with over 75% (854/1129) of participants completing the study duration."

Observational data • Migraine

Improving the Perception of Stress and Mutuality in Caregivers (MI-DEAR Study) of Migraine Patients With Depressive Symptoms Treated With Fremanezumab: A Study to Evaluate Whether Fremanezumab Reduces the Impact on Caregivers and Increases Couple Reciprocity (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

New trial • CNS Disorders • Migraine • Pain

Assessment of Pharmacokinetic and Pharmacodynamic Drug-Drug Interactions with Nipocalimab and Relevance to Patients with Rheumatic Diseases (EULAR 2025) - "When used together with etanercept in patients with RA, nipocalimab may increase the clearance of etanercept via non-specific pinocytosis and blockade of FcRn and other mechanisms such as target mediated drug disposition or immunogenicity-mediated clearance, etc.[2] In addition, hydroxychloroquine (HCQ) is an immunosuppressive therapy often used in rheumatic diseases such as Sjögren’s disease (SjD), systemic lupus erythematosus (SLE), and RA, may raise the lysosomal pH[3] which may have the potential to impact the degradation of IgG, and thus may blunt the IgG lowering effect of nipocalimab, thereby causing a pharmacodynamic (PD) DDI. Decreases in PK exposure for both fremanezumab and etanercept with co-administration of nipocalimab were observed. There was a lack of HCQ impact on nipocalimab’s PD effect. There was no impact of fremanezumab, etanercept, or HCQ on nipocalimab PK in both studies."

Clinical • PK/PD data • CNS Disorders • Inflammatory Arthritis • Lupus • Migraine • Oncology • Pain • Rheumatoid Arthritis • Rheumatology • Sjogren's Syndrome • Systemic Lupus Erythematosus • TNFA

Evaluating the Effectiveness and Safety of Fremanezumab in Adults With Migraine and Obesity: A Phase 4 Retrospective Chart Review Study (AHS 2025) - No abstract available

Late-breaking abstract • P4 data • Retrospective data • Review • CNS Disorders • Migraine • Pain

Retrospective cohort study of anti-CGRP monoclonal antibody unresponsive migraine individuals treated with atogepant: The RESCUE study. (PubMed, Cephalalgia) - "Prior use of anti-CGRP mAbs included erenumab in 11.4% of participants, galcanezumab in 52.3% and fremanezumab in 86.3%. Five (11.4%) participants discontinued treatment due to side effects.ConclusionsAfter three months of treatment, atogepant led to a clinically meaningful improvement in a subset of participants. It may be a valuable preventive option for individuals unresponsive to anti-CGRP mAbs and warrants further investigation in prospective studies."

Journal • Retrospective data • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

A real-world study of the efficacy and tolerability of fremanezumab in migraine patients with a median follow-up of 14 months. (PubMed, Neurol Res Pract) - "Fremanezumab is effective and well tolerated for long-term migraine prophylaxis."

Journal • Real-world evidence • CNS Disorders • Migraine • Pain • Psychiatry