Teva Pharmaceuticals has announced positive results from post-hoc analysis of the Phase III HALO-LTS and FOCUS clinical trials that assessed Ajovy (fremanezumab) in patients with migraine and co-morbid obesity.
The post-hoc analysis of both studies demonstrated the safety and efficacy of Ajovy in high body mass index (BMI) patients compared to normal-BMI patients. After six months of treatment, monthly migraine days in patients with a high BMI were reduced to 6.8 compared to 7.2 days in patients with a normal BMI. Monthly migraine days at baseline were 13.7 in high-BMI patients compared to 13.6 in normal-BMI patients.
The Israeli company showcased the data at the European Headache Congress, which is taking place in Barcelona on 6-9 December 2023.
The Phase III HALO-LTS study (NCT02638103), which enrolled 1890 subjects, met its primary endpoints, including the number of participants with adverse events, injection site reactions, and potentially clinically significant abnormal serum chemistry results. Secondary outcomes included a change from baseline in the monthly average number of migraine days during the four-week period at month 12.
The FOCUS study (NCT03308968) enrolled 875 patients across 104 sites. The Phase III trial evaluated the safety and efficacy of monthly and quarterly subcutaneous injections of Ajovy compared to placebo in subjects with chronic migraine or episodic migraine. The trial met its primary endpoint of a change from baseline in the monthly average number of migraine days during the 12-week period after the first dose of Ajovy.
In the announcement accompanying the results, lead study author Dr Pablo Irimia Sieira said: “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.”
At the start of this year, Teva Pharmaceuticals found themselves in a lawsuit over Ajovy when the company accused Eli Lilly’s Emgality (galcanezumab) of infringing on patent rights. A district judge sided with Lilly, overturning a $176.5m jury ruling in September 2023.
The humanised monoclonal antibody (mAb) Ajovy gained US Food and Drug Administration (FDA) approval in 2018 for the preventive treatment of migraine in adults with at least four migraine days per month.
According to GlobalData’s Pharma Intelligence Center, Ajovy is forecasted to generate $777m in sales in 2029.
GlobalData is the parent company of Clinical Trials Arena.
