Teva Pharmaceutical’s Ajovy (fremanezumab) reduced migraines and depression symptoms in patients according to data unveiled from the company’s UNITE trial.
Presented earlier this month at the World Congress of Neurology in Montreal, Canada, the positive results were from a double-blind, randomised, placebo-controlled Phase IV clinical trial (NCT04041284) investigating the drug’s efficacy, safety, and clinical impact in 353 patients with migraines and major depressive disorder.
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Ajovy, which is a humanised monoclonal antibody (mAb), is already approved for the preventive treatment of migraine in adults, with the US Food and Drug Administration greenlighting the drug in September 2018.
Data from the UNITE trial showed that patients who received monthly 225mg subcutaneous Ajovy experienced on average 5.1 fewer monthly migraine days, compared to 2.9 in the placebo group. During the 12-week double-blind period, 33% of patients receiving the treatment achieved a greater than 50% reduction in monthly migraine days, compared to the placebo group’s 13%.
Teva also unveiled results showing significant reductions in depression symptoms. At week 12, patients taking Ajovy had a 6.7 mean reduction on the Hamilton Rating Scale for Depression (HAM-D 17). The placebo group exhibited a 5.4 score lowering.
Study lead author Dr Richard Lipton said: “Depression is commonly associated with migraine, and clinicians are increasingly aware of the impact of co-morbidities. We are moving towards more personalised treatment decisions in migraine which are tailored to the patient’s profile, and it is very important for treatments to demonstrate efficacy and safety in migraine patients with this particular co-morbidity.”
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By GlobalDataAjovy was the subject of a lawsuit earlier this year when Teva claimed that Eli Lilly’s Emgality (galcanezumab) infringed on patent rights. In September 2023, a district judge ruled in favour of the US pharma giant Lilly, overturning a previous $176.5m jury ruling.
