Teva announces new post hoc analysis of two Ajovy clinical studies

Teva announced that a post hoc analysis of two phase 3 clinical studies presented at the European Headache Congress has shown the effectiveness of the migraine prevention treatment Ajovy in reducing migraine attacks in patients with migraine and co-morbid obesity. Migraine and obesity are both associated with high levels of disability and both conditions are more prevalent amongst females. It is estimated that 59% of people in Europe are either overweight or obese, with almost a quarter of adults living with obesity. A higher body mass index (BMI) is frequently associated with increased migraine prevalence and severity, and an increased number of adverse effects. As such, assessing the efficacy and safety of migraine preventative treatment in patients with obesity can help guide migraine management and treatment decisions. The post hoc analysis of the HALO-LTS1 and FOCUS2 phase 3 studies compared the safety and efficacy of fremanezumab migraine preventive treatment in obese migraine patients vs normal weight migraine patients for a period of six months. Obesity was defined as having a Body Mass Index greater than or equal to30 kg/m2 and normal weight patients with a BMI less than 30 kg/m2. The analysis showed that the efficacy of fremanezumab was the same in migraine patients with BMI-high vs BMI-normal: At baseline, monthly migraine days in migraine patients with BMI-high vs BMI-normal were 13.7 vs 13.6 respectively. After 6 months of treatment with fremanezumab, monthly migraine days in migraine patients with BMI-high vs BMI-normal was reduced to 6.8 vs 7.2 respectively. Furthermore, adverse events, or AEs, in patients with obesity were similar to AEs in non-obese patients treated with fremanezumab.