EHC 2025: Teva’s PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY® for the Prevention of Chronic and Episodic Migraine

Final Analysis from Teva’s PEARL Real-World Study Reinforces the Evidence for the Long-term Effectiveness of AJOVY^® (fremanezumab) for the Prevention of Chronic and Episodic Migraine

• Final analysis of PEARL real world migraine prevention study being presented at the European Headache Congress (EHC 2025) in Lisbon 3- 6 December 2025^1,2
• Fremanezumab demonstrated sustained effectiveness and a favourable safety and tolerability profile over the two-year study period^1,2
• Injection adherence remained high throughout the study (~90%), while over 75% of patients completed the study duration¹

HAARLEM, NETHERLANDS, 3^rd December 2025 – Teva Pharmaceuticals Europe B.V announce that the final analysis of the real-world pan-European PEARL Phase 4 migraine prevention study has shown that AJOVY^® (fremanezumab), an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, delivered sustained effectiveness over a two-year period in reducing frequency, duration and severity of migraine attacks in patients with chronic and episodic migraine.¹

The final analysis from PEARL, a 24-month real-world observational study assessing the impact of fremanezumab for migraine prevention in 1,140 patients, living with either episodic migraine (EM) or chronic migraine (CM), is being presented at the European Headache Congress (EHC 2025) in Lisbon.

The data confirmed that the primary and secondary endpoints had been met, with over 66% (248) of patients with EM and 51.6% (386) with CM achieving the primary endpoint of a ≥50% reduction in Monthly Migraine Days (MMD) during the first 6 months of treatment. The participants also benefitted from sustained migraine prevention for over 24 months. Injection adherence rates remained high (~90%), with over 75% (854/1129) of participants completing the study to the end.¹

Presenting the efficacy data, Isabel Pavão Martins, Professor of Neurology at the Faculty of Medicine, University of Lisbon said “PEARL has consistently demonstrated the real-world benefits of migraine prevention with fremanezumab in patients suffering from episodic and chronic migraines. The findings underscore the sustained effectiveness, strong treatment adherence, and persistence over a two-year follow-up period, reinforcing its clinical value for migraine prevention.”

All participants were also enrolled in a safety analysis, which showed that 56.3% (642/1140) participants reported ≥1 adverse effect (AE) and drug-related serious AEs were infrequent, occurring in 0.4% (4) of participants, demonstrating the long-term safety and tolerability of fremanezumab.^1,2

Presenting the safety data, Dr Gürdal Sahin, Department of Clinical Sciences, Lund University, Skåneuro Neurology Clinic, Lund, Sweden said “All enrolled participants were included in the safety analysis of fremanezumab, and the results further strengthen the evidence supporting its long-term safety and tolerability. These findings are consistent with the previously demonstrated safety profile from earlier PEARL analyses and provide additional reassurance for its use in clinical practice.”

Pinar Kokturk, M.D., Vice President and Head of Medical Affairs Europe at Teva said

“PEARL has consistently demonstrated the clinical benefits of long-term fremanezumab use in patients burdened with debilitating migraine. This condition remains the second leading cause of disability worldwide³, placing a significant burden on patients who face high disease impact and an urgent need for effective preventive treatment options. To improve patient outcomes, migraine prevention must be a priority for clinicians and the results from PEARL confirm that achieving this goal is possible.”

Editors’ Notes

PEARL (Pan-European Real-World study), a two-year prospective, observational Phase IV study is investigating the effectiveness of AJOVY® (fremanezumab) in 1140 patients with chronic or episodic migraine. Fremanezumab is a humanised monoclonal antibody (mAb) that selectively targets the calcitonin gene-related peptide (CGRP) pathway. Of the 1140 participants enrolled, 1129 were included in the effectiveness analysis (EM, 33.1%; CM, 66.9%; 87.2% female). Eligible participants were adults with EM or CM receiving fremanezumab for migraine prevention, who maintained a daily headache diary prior to and throughout the study period. The primary endpoint was the proportion of participants with >=50% reduction in monthly migraine days (MMD) during the 6-month period after fremanezumab initiation. Secondary endpoints across Months 1–24 included mean change from baseline in MMD, and treatment adherence (participants who took their prescribed dose within ±5 days of the scheduled monthly/quarterly dosing regimen, per injection) and persistence.

About AJOVY^® (fremanezumab-vfrm) injection 
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly

dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a health care professional or at home by a patient or caregiver. No starting dose is required to begin treatment. 

Information for Europe about AJOVY can be found here. 

About Teva 

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements 

This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AJOVY (fremanezumab) for the prevention of chronic or episodic migraine; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

References

1. 1.  Ashina M. et al, Real-World Effectiveness of Fremanezumab in Migraine Prevention: Final Outcomes of the Pan-European PEARL Study (P206), poster presented at the European Headache Congress (EHC); 3-6 December 2025; Lisbon, Portugal.
2. Ashina M et al, Real-World Safety and Tolerability of Fremanezumab in Migraine Prevention: Final Outcomes of the PEARL Study (P207), poster presented at the European Headache Congress (EHC);3-6 December 2025; Lisbon, Portugal.
3. Steiner, T.J., Stovner, L.J., Jensen, R. et al.Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain21, 137 (2020).