Fremanezumab Found Effective for Migraines, Comorbid Anxiety and Depression


Teva Pharmaceutical Industries announced that fremanezumab can successfully reduce 2 common migraine comorbid symptoms—anxiety and depression.

Fremanezumab (Ajovy; Teva Pharmaceutical Industries Ltd) was found to be an effective treatment for patients with migraine who experience associated depression and anxiety. Fremanezumab is indicated to prevent migraines in adults who have more than 4 migraine days each month. The results of the analyses were presented at the Migraine Trust International Symposium (MTIS).

“Clinicians are becoming increasingly aware of the impact that comorbidities can have on the management of migraine patients…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 comorbidities,” said Richard Lipton, MD, Department of Neurology, Psychiatry and Behavioural Sciences, Albert Einstein College of Medicine, New York, in a press release.

Approximately 50% of all migraine patients experience depression and anxiety. These comorbidities have been associated with a lower quality of life, pain, and disability. Lipton and team set to analyze the efficacy of quarterly or monthly dosing of fremanezumab for migraine patients with 1 or more psychiatric comorbidities compared with placebo.

The team pooled and analyzed data from the previous 6-month-long HALO and FOCUS studies. FOCUS, led by Patricia Pozo-Rosich, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Research, Barcelona, Spain, was a double-blind, placebo-controlled phase 3b study. The trial analyzed taking a quarterly versus monthly dose of fremanezumab for chronic or episodic migraine patients who had unsuccessfully tried 2 to 4 migraine prevention medications.

Lipton found that 32% of patients who took fremanezumab quarterly, and 36% who took it monthly, had more than a 50% reduction in monthly-migraine-days (MMD) compared with 19% in the placebo group.

The second study, a sub-analysis of patients from the FOCUS study, evaluated the efficacy of fremanezumab on migraine patients with a depression comorbidity. The researchers found fremanezumab reduced MMDs and monthly-headache days in both the quarterly and monthly groups. Investigators also administered a patient-reported questionnaire, which indicated that fremanezumb reduced depressive symptoms.

Lipton will be leading a 28-week study called UNITE to “help inform treatment decisions” for chronic and episodic migraine patients with major depressive disorder. Lipton said that the study has enrolled 237 patients from the United States, Europe, and other countries around the world so far.

“Teva is strongly committed to supporting further research into the role of fremanezumab in managing the full spectrum of migraine patients,” said Dieter Schultewolter, MD, vice president of Global Medical Affairs Neuroscience at Teva, in the press release. We see this as an important step towards a much needed personalized treatment approach for people suffering from migraines in the future.”


Teva Pharmaceutical Industries Ltd. Studies Show Effectiveness of AJOVY® (fremanezumab) for Treatment of Migraine in Patients With Co-morbid Depression. Teva Pharmaceutical Industries Ltd. website. September 8, 2022. Accessed on September 8, 2022.

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