Teva to Present Data at the 2023 American Headache Society Annual Scientific Meeting Demonstrating AJOVY (fremanezumab-vfrm) Injection Significantly Reduced Migraine and Depression Symptoms in Patients

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that six abstracts revealing benefits of AJOVY (fremanezumab-vfrm) injection in patients with migraine will be presented at the 2023 American Headache Society (AHS) Annual Scientific Meeting, held June 15-18 in Austin, Texas.

Featured data will include an oral presentation of the Phase 4 UNITE randomized clinical study, investigating the efficacy and safety of AJOVY for preventive treatment in patients with migraine and comorbid major depressive disorder. Results showed that treatment with AJOVY was associated with statistically significant reductions in migraine days as well as reductions in symptoms of depression (HAMD-17 and PHQ-9 scores) over 12 weeks in patients with migraine and major depressive disorder.

“Patients who suffer from migraine and mental health disorders such as depression face a greater burden than those suffering from only one disease, and have higher risks for medication overuse, poorer quality of life and greater disability if untreated,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “The data we are presenting at AHS provide further insights into the potential efficacy, safety, and quality of life benefits of AJOVY for people with migraine and major depressive disorder.”

Additional presentations at AHS will include:

• Health economics and outcomes research (HEOR) analyses examining the health care resource use pattern during the individual AJOVY treatment cycle and modeling potential cost impact associated with early initiation of AJOVY in the treatment pathway; and
• Findings from the FINESSE study, a real-world, prospective, observational study to evaluate the effectiveness of AJOVY in patients with chronic and episodic migraine, including those for whom another calcitonin gene-related peptide (CGRP) pathway monoclonal antibody has failed.

The 2023 AHS Annual Scientific Meeting is being offered both in-person and virtually. Data presentations can be accessed by registering for the meeting.

The full set of Teva-sponsored AJOVY data to be presented includes:

UNITE
UNITE was a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study followed by a 12-week open-label extension (OLE) period. The study aimed to evaluate the efficacy and safety of AJOVY in adults with migraine and major depressive disorder. Patients were randomized 1:1 to receive 225 mg subcutaneous monthly AJOVY or matched placebo for 12 weeks.