27 May 2020 - - Israeli drugmaker Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) recently presented a wide range of important new data on Ajovy (fremanezumab) and the societal and economic impact of migraine in Europe at the 6th Congress of the European Academy of Neurology, the company said.

This year's EAN congress was a virtual meeting due to the global coronavirus pandemic.

The fremanezumab data included pooled analyses of the AJOVY Phase 3 clinical trials (FOCUS, HALO-episodic migraine and HALO-chronic migraine) which focused on the safety, efficacy and improved quality-of-life for patients experiencing difficult-to-treat migraine.

Post-hoc analyses were also evaluated in patients who may experience challenges when managing their migraine due to comorbidities.

Migraine creates a significant disease and economic burden. With more than one bn people impacted globallyi, migraine is the second leading global cause of years lived with disabilityii and annual costs of the disease in the US and EU are USD 200bn.

Pooled analyses of the Phase 3 FOCUS, HALO-EM and HALO-CM clinical trials in patients 60 years of age or older with EM or CM, examined treatment with fremanezumab versus placebo over 12 weeks.

Reductions from baseline in monthly migraine days, headache days of at least moderate severity, and days with acute headache medication use over 12 weeks were significantly greater with quarterly and monthly fremanezumab versus placebo (all P≤0.0103).

The analyses also examined early onset of efficacy and improved headache-related disability, health-related quality-of-life, productivity, and satisfaction in this patient population.

Additionally, the analyses looked at cardiovascular adverse events in fremanezumab and placebo treated patients in this group, regardless of whether or not they had a cardiovascular medical history.

Additional pooled analyses of the Phase 3 trials were also conducted to examine cardiovascular safety across all patients.

The analyses were performed in migraine patients with cardiovascular/cerebrovascular risk factors (e.g., diabetes mellitus, hyperlipidemia, obesity, hypertension, hormonal birth control pill use) (n=499).

The overall incidence of cardiovascular adverse events in these patients were low and comparable between fremanezumab and placebo treated groups.

An increase in the number of risk factors did not seem to correlate with an increase in frequency of cardiac and vascular adverse events.

Additionally, the analyses examined patients with migraine using cardiovascular medications at baseline (n=280), and patients using concomitant triptans (n=1,123) with those who did not use triptans.

Similar to the overall trial populations, the most common adverse events reported in all of these subgroups were injection site reactions.

Two analyses evaluated the economic and disease burden of migraine across patients in the United Kingdom, France and Spain. The first analysis found that CM patients experienced greater disability caused by migraine versus EM patients.

CM patients also reported lower health status than EM patients for their most recent migraine.

The second evaluation, which included examining electronic medical records from 84,266 adult patients with EM and CM, found CM patients had more migraine-related consultations with their general practitioners than EM patients.

Additionally, average quarterly treatment costs were higher for CM patients in all three countries.

These results point to substantial migraine disability and unmet treatment needs across the three countries. They also associate migraine with a significant healthcare and economic burden that includes higher costs for CM patients.

The ePresentations and ePosters shared by Teva at EAN can be accessed by healthcare professionals through the EAN conference website. The sessions will be available at no cost and will also be on-demand for EAN members from 27 May onward.

Additional resources on migraine, including articles, videos, publications summaries, podcasts and webinars can be accessed on Neurologybytes.

Neurologybytes is a platform published by Teva to support neurologists in accessing timely, bite-sized content on the latest research developments and clinical care perspectives in the world of migraine and multiple sclerosis.