Analysis assessed migraine days at the beginning and end of quarterly and monthly dosing intervals
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced results from a post hoc analysis of a long-term, open-label extension study assessing migraine days at the beginning and end of quarterly and monthly dosing intervals of AJOVY® (fremanezumab-vfrm) injection. The results were published in the October issue of Headache: The Journal of Head and Face Pain.
"We are proud to share this analysis and demonstrate our continued commitment to advancing the understanding of treatment options for patients living with migraine," said Denisa Hurtukova, MD, Vice President, Head of North America Medical Affairs, Teva. "This analysis helps us better understand patients' experience with AJOVY, as well as the impact of quarterly and monthly dosing options."
The post hoc analysis compared migraine days in the initial and final weeks of quarterly or monthly dosing regimens of AJOVY during up to 15 months of treatment. The analysis included 1,043 patients with chronic migraine (CM) (n=611) and episodic migraine (EM) (n=432) who were initially enrolled in the pivotal placebo controlled HALO CM and EM studies and then continued in the long-term, 12-month, multicenter, randomized, parallel group Phase 3 study with double blind dosing regimens. Patients received AJOVY either quarterly or monthly.
"Utilizing patients within each dosing group as their own control, we were able to analyze whether there was variability in migraine days over the course of a dosing regimen. For all time intervals analyzed, the frequency of migraine days was the same in the beginning and end of the dosing period," said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Therapeutic Area Lead for Migraine & Headache, Teva.
"This is an important analysis for the migraine community since clinical symptoms often return or worsen before the next dose of many preventive migraine medications is due," said Andrew Blumenfeld, MD, Headache Center of Southern California, The Neurology Center, Carlsbad, CA. "Migraine can be a debilitating disease, so evaluating migraine days throughout a dosing regimen can be significant for healthcare providers when considering treatment options. Whenever the brain is exposed to a migraine attack, there is the possibility of increased sensitization with progressive worsening of the frequency of migraine. A key clinical goal is to limit the amount of time the brain is exposed to migraine to reduce this risk and the number of migraine days impacting a patient before their next dose."
The mean weekly number of migraine days at baseline was 4.0 for patients with CM taking quarterly or monthly AJOVY. For patients with EM, the mean weekly number of migraine days at baseline in the quarterly and monthly AJOVY groups were both 2.3 days.