AJOVY®▼ (fremanezumab) for treatment of migraine in patients with co-morbid depression

  • Two separate analyses1,2 presented at the Migraine Trust International Symposium (MTIS) demonstrate the effectiveness of AJOVY▼(fremanezumab) for the treatment of migraine in patients with migraine and co-morbid depression
  • Depression and anxiety are common co-morbidities experienced by around half of all patients with migraine3,4  and are associated with more pain, disability and a reduced quality of life1,2
  • AJOVY▼(fremanezumab) has been shown to be an effective migraine preventive treatment in a range of patients including those with depression and anxiety5,6,7

Teva Pharmaceutical  Industries Ltd. announced on 8th September 2022 the results of two studies1,2 presented at the Migraine Trust International Symposium (MTIS) in London, UK, which demonstrate the efficacy of AJOVY▼ (fremanezumab) in migraine patients who also experience depression or anxiety.  AJOVY▼ (fremanezumab) is indicated for the prevention of migraine in adults with at least 4 migraine days per month.8

In both studies, quarterly and monthly dosing of fremanezumab demonstrated efficacy in reducing monthly migraine attacks by more than 50% compared to placebo.1,2 This is an important outcome because psychiatric disorders are a common co-morbidity in patients suffering from migraine. Population-based samples of people with migraine show up to 47% have co-morbid depression, and up to 58% have co-morbid anxiety4 with many patients experiencing both psychiatric conditions.

The first study1 relating to this patient cohort was led by Richard Lipton MD, Department of Neurology, Psychiatry and Behavioural Sciences at Albert Einstein College of Medicine, New York.  This study is an analysis of pooled data from two previous six-month studies: HALO and FOCUS. The new study to be presented at MTIS sets out to analyse the efficacy of quarterly or monthly dosing of fremanezumab versus placebo in people with migraine and one or more psychiatric co-morbidities.1

Results at three months showed that 32% of patients on quarterly fremanezumab (n=61) and 36% of patients on monthly fremanezumab (n=75) achieved a ≥ 50% reduction in monthly-migraine-days (MMD) compared to 19% of those taking placebo (n=42), and that proportion increased after continuing or switching to fremanezumab at month six.1

The second study2 is a sub-analysis of patients from the double-blind, placebo-controlled phase 3b FOCUS study led by Patricia Pozo-Rosich, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Research, Barcelona. The FOCUS study set out to evaluate the efficacy of quarterly or monthly fremanezumab in chronic or episodic migraine patients who had experienced an inadequate response to two to four classes of prior preventive migraine medication. The sub-analysis evaluated treatment efficacy on a sub-group of the migraine patients who had co-morbid depression.2

Reductions were observed in both monthly-migraine-days and monthly-headache-days with both quarterly and monthly fremanezumab compared with placebo. Differences were also seen in patient-reported depressive symptoms using a PHQ-9 questionnaire – a brief self-reporting instrument incorporating recognised depression criteria and other depressive symptoms9 suggesting that effective treatment of migraine can also positively impact depressive symptoms in patients with this co-morbidity.

Clinicians are becoming increasingly aware of the impact that co-morbidities can have on the management of migraine patients. I believe that we need to move towards more personalised treatment decisions that are tailored to the patient’s profile and co-morbidities. As depression and anxiety are commonly associated with migraine, it will be very important for treatments to demonstrate efficacy and safety in migraine patients with these particular co-morbidities.

Dr. Richard Lipton

Details of enrolment progress into the UNITE study were also revealed at MTIS.10 The 28-week study, led by Dr. Richard Lipton and supported by Teva, will be assessing the efficacy and safety of fremanezumab in adult patients with chronic and episodic migraine and major depressive disorder.  

Commenting on the study, Dr. Lipton said: “We are pleased to report that a total of237 patients have so far enrolled in the UNITE study with 19% from the U.S., 61% from Europe, and 20% from the rest of the world. Assessing the efficacy of fremanezumab in patients with migraine and major depressive disorder will help inform treatment decisions to improve care in this important patient population. We look forward to sharing the results in due course.”

Dr. Dieter Schultewolter, Vice President of Global Medical Affairs Neuroscience at Teva, said: “Teva is strongly committed to supporting further research into the role of fremanezumab in managing the full spectrum of migraine patients, including those who suffer from co-morbid depression and anxiety. We see this as an important step towards a much needed personalised treatment approach for people suffering from migraine in the future.” 


  1. Lipton et al. Efficacy of Quarterly and Monthly Fremanezumab in Patients With Migraine and Psychiatric Comorbidities. Abstract accepted for MTIS 2022. MTIS2022-229 
  2. Pozo-Rosich et al. Fremanezumab Efficacy in Migraine Patients With Prior Inadequate Response to ≥3 Preventive Migraine Medication Classes and Depressive Symptoms. Abstract accepted for MTIS 2022. MTIS2022-230
  3. Lanteri-Minet et al. Anxiety and depression associated with migraine: Influence on migraine subjects’ disability and quality of life, and acute migraine management. Pain. 2005; 118: 319- 326.
  4. Minen et al. Migraine and its psychiatric comorbidities. J Neurol Neurosurg Psychiatry. 2016; 87: 741- 749.
  5. Lipton et al. Long-Term Efficacy of Fremanezumab in Patients with Chronic Migraine and Comorbid Moderate to Severe Depression. Presented at the American Academy of Neurology 61st Annual Meeting Philadelphia, Pennsylvania, USA May 4–10, 2019.  P144
  6. Winner et al. Long-Term Efficacy of Fremanezumab in Chronic and Episodic Migraine Patients Who Failed at Least One Prior Migraine Preventive Medication: Results of a 1-Year Study. Presented at the American Headache Society 61st Annual Scientific Meeting, Philadelphia, Pennsylvania, USA July 11–14, 2019. P151
  7. Silberstein et al. Long-Term Efficacy of Fremanezumab in Chronic and Episodic Migraine Patients with Acute Medication Overuse at Baseline: Results of a 1-Year Study. Presented at the American Headache Society 61st Annual Scientific Meeting, Philadelphia, Pennsylvania, USA July 11–14, 2019. P107
  8. Ajovy EU SmPC  https://www.ema.europa.eu/en/documents/product-information/ajovy-epar-product-information_en.pdf [accessed 26 August 2022]
  9. PHQ-9 assessment tool. https://www.apa.org/pi/about/publications/caregivers/practice-settings/assessment/tools/patient-health [accessed 26 August 2022]
  10. Lipton et al. A Phase 4 Study of Fremanezumab for Preventive Migraine Treatment in Patients With Major Depressive Disorder: Baseline Patient Characteristics in UNITE.  Abstract accepted for MTIS 2022. MTIS2022-231

About AJOVYq (fremanezumab-vfrm) injection
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. AJOVYq European SmPC can be found here.

▼This medicinal product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at http://www.hpra.ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com