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

Fremanezumab initiation at early disease stages may improve migraine outcomes: post hoc analysis of the PEARL study (IHC 2025) - No abstract available

Retrospective data • CNS Disorders • Migraine

Interim results from a post-marketing surveillance study of patients with migraine treated with fremanezumab in Korea (IHC 2025) - No abstract available

Clinical • Late-breaking abstract • P4 data • CNS Disorders • Migraine

US FDA approves Teva’s Ajovy for migraine prevention in children (Reuters) - "The U.S. Food and Drug Administration on Tuesday approved Ajovy, an injection made by Israeli drugmaker Teva Pharma...to help prevent migraines in children aged six and older who weigh 45 kilograms or more. This is the first time a drug has been approved for preventing migraines in children....The injection is given once a month. The most common side effects are pain and redness where the shot is given....The treatment was first approved for adults in 2018..."

FDA approval • Migraine • Pain

Effects of Pausing and Re-Initiating Fremanezumab After Continuous 24-Month Treatment for Preventing Difficult-To-Treat Migraine: Prospective, Multicenter, Real-World Data From the GRASP Study Group. (PubMed, Eur J Neurol) - "Discontinuation of fremanezumab after month 24 leads to rising MMD/MHDs. After fremanezumab re-initiation, a relatively reduced effectiveness in the first 3 months might occur, compared with the pre-fremanezumab cessation. Overall, our findings doubt the rationale behind mandated anti-CGRP treatment pauses in migraine prophylaxis."

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

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

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

Real world effectiveness of anti-CGRP monoclonal antibodies over three consecutive one-year treatment cycles: An intention-to-treat analysis. (PubMed, Cephalalgia) - "The ITT analysis revealed a remaining high burden of disease. While confirming mAbs effectiveness in migraine prevention, these findings underscore the need for more treatment approaches and for exploring other non-CGRP dependent pathways."

Journal • Real-world evidence • CNS Disorders • 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

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