Teva's Ajovy Shows Similar Efficacy Reducing Migraine Attacks in Patients With Obesity

A pair of Phase 3 studies demonstrated the efficacy of Ajovy (fremanezumab; Teva Pharmaceutical Industries Ltd.) in decreasing migraine attacks in patients with comorbid obesity. The findings, presented at the European Headache Congress, indicate similar efficacy for the drug in treating migraine headaches in both obese and non-obese patients.

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“This analysis is encouraging as it shows fremanezumab can reduce migraine attacks as effectively in obese patients as it does in patients of normal weight,” said lead study author, consultant neurologist Dr. Pablo Irimia Sieira, of Clinica Universidad de Navarra, Pamplona, Spain, in a press release. “Considering the higher burden of migraine in patients with co-morbid obesity, it is important for treatments to demonstrate efficacy and safety in migraine patients with this particular comorbidity.”

Ajovy is a humanized monoclonal antibody (mAb) that selectively targets the calcitonin gene-related peptide (CGRP). The drug was approved in 2018 for the prevention of migraine in adults who have at least four migraine days per month. Ajovy is available as a 225 mg/1.5 mL single-dose injection in a prefilled syringe or autoinjector. The treatment has two dosing options at 225 mg administered monthly as one subcutaneous injection or 675 mg every three months administered as three subcutaneous injections.

Ajovy was the second FDA-approved preventive migraine treatment in a new class of drugs that act by blocking the activity of CGRP, a molecule involved in migraine attacks. The first FDA-approved drug in this class was Aimovig (erenumab-aooe), which also gained approval in 2018.

Migraine headache pain is frequently described as an intense pulsing or throbbing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Migraine attacks may produce significant and potentially disabling pain for hours to days at time.

Migraine with comorbid obesity have been found to cause high levels of disability and are both more common in female patients. Higher body mass index (BMI) has been found to be commonly associated with greater migraine prevalence and severity, as well as an elevated frequency of adverse effects (AEs).

The data presented at the European Headache Congress were from a post hoc analysis of the Phase 3 HALO-LTS1 and FOCUS2 trials, which evaluated the safety and efficacy of Ajovy at preventing migraine attacks in patients with obesity compared with individuals of normal weight over a period of six months. Obesity was defined as a body mass index (BMI) of ≥30 kg/m2 (BMI-high, 578 patients) with normal weight defined as a BMI of <30 kg/m2 (BMI-normal, 1859 patients). The data show that at baseline, monthly migraine days in patients with obesity was 13.7 compared with 13.6 among normal weight patients.

Further, after six months of treatment with Ajovy, monthly migraine days in obese patients dropped to 6.8 compared with 7.2 among normal weight patients. Additionally, AEs were similar among both patient cohorts administered Ajovy.

“We are seeing clinicians moving towards more personalised treatment decisions in migraine, which are tailored to the patient’s profile,” said Teva Vice President of Global Medical Affairs Neuroscience Dr. Dieter Schultewolter, in a press release. “So, it is informative to see that the efficacy of fremanezumab for migraine prevention has now been demonstrated across multiple subgroups, including those with older age, obesity, psychiatric comorbidities like depression, and difficult-to-treat migraine.”

References

New Post Hoc Phase 3 Data Analysis Shows AJOVY® (fremanezumab) Reduced Migraine Attacks in Adults with Migraine and Co-morbid Obesity. Teva Pharmaceutical Industries Ltd. News release. December 6, 2023. Accessed December 7, 2023. https://www.tevapharm.com/news-and-media/latest-news/new-post-hoc-phase-3-data-analysis-shows-ajovy-fremanezumab-reduced-migraine-attacks-in-adults-with-mi/