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

Rhea-AI Summary

Teva Pharmaceuticals (TEVA) announced final results from its two-year PEARL Phase 4 real-world study of AJOVY (fremanezumab) for migraine prevention. The study, presented at EAN 2025 Congress, demonstrated sustained effectiveness in reducing migraine frequency, duration, and severity in both chronic and episodic migraine patients. The study of 1,140 patients showed that over 66% of episodic migraine patients and 51.6% of chronic migraine patients achieved ≥50% reduction in Monthly Migraine Days (MMD) during the first 6 months, with benefits sustained over 24 months. Notable outcomes include high injection adherence rates (~90%) and strong study completion rate (75%). The drug maintained a favorable safety and tolerability profile throughout the study period, consistent with previous trials.

Positive

• Over 66% of episodic migraine patients and 51.6% of chronic migraine patients achieved ≥50% reduction in Monthly Migraine Days
• High injection adherence rate of ~90% throughout the study period
• Strong study completion rate of over 75% (854/1129 participants)
• Favorable long-term safety and tolerability profile consistent with previous trials

Negative

• None.

Insights

Pharmaceutical Analyst

Teva's AJOVY shows sustained 2-year effectiveness in real-world migraine prevention study, reinforcing its long-term commercial potential.

The final data from Teva's PEARL real-world study provides strong validation for AJOVY's commercial positioning in the competitive CGRP inhibitor market. The study demonstrated that fremanezumab maintained its effectiveness over a full 24-month period, with 66% of episodic migraine patients and 51.6% of chronic migraine patients achieving the primary endpoint of ≥50% reduction in monthly migraine days.

Two metrics particularly stand out for investors: the ~90% injection adherence rate and 75% study completion rate. These figures suggest strong patient satisfaction and treatment persistence, critical factors for recurring revenue in chronic disease medications. The favorable safety and tolerability profile further supports AJOVY's potential for long-term prescription sustainability.

The real-world nature of this study is especially valuable, as it confirms that AJOVY's efficacy extends beyond controlled clinical trials into everyday clinical practice across European markets. With migraine being the second leading cause of disability worldwide, these results strengthen Teva's position in neurological disorders, a therapeutic area that continues to see significant market growth.

For context, the anti-CGRP migraine prevention market has become increasingly competitive with Amgen/Novartis's Aimovig, Eli Lilly's Emgality, and newer entrants competing alongside AJOVY. These long-term effectiveness data provide Teva with compelling differentiation points for payer negotiations and physician education efforts, potentially supporting market share maintenance or growth in this valuable therapeutic category.

• Final analysis of PEARL real world migraine prevention study presented at 11th Congress of the European Academy of Neurology (EAN 2025) Congress in Helsinki^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
  

TEL AVIV, Israel, June 23, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the final analysis of the pan-European PEARL Phase 4 migraine prevention study showed 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 data was presented at the Congress of the European Academy of Neurology (EAN 2025) congress in Helsinki confirming that primary and secondary endpoints had been met.¹ Investigators concluded that the findings underscore the sustained effectiveness and the robust injection adherence rates to long-term fremanezumab treatment in migraine prevention.¹

“Over the last two years, we have observed the benefit of fremanezumab for sustained migraine prevention and its positive impact on patient outcomes,” says Messoud Ashina, Professor and Director of the Human Migraine Research Unit, the Danish Headache Center and Department of Neurology. “The PEARL study has provided valuable insight, not only
into the pivotal role that fremanezumab can play in migraine prevention, but also in the importance of real-world studies in helping build our knowledge and shape clinical practice.”

PEARL, a 24-month real-world observational study assessed the impact of fremanezumab for migraine prevention in 1,140 patients, predominantly female (87.25%) with 33.1% living with episodic migraine (EM), and 66.9% with chronic migraine (CM). The final study showed

that over 66% of patients with EM and 51.6% with CM who had achieved the primary endpoint of a ≥50% reduction in Monthly Migraine Days (MMD) during the first 6 months of treatment benefitted from sustained migraine prevention for over 24 months. Injection adherence rates remained high throughout (~90%) the study, with over 75% (854/1129) of participants completing the study duration.¹

The investigators also noted the favourable long-term safety and tolerability of fremanezumab that was consistent with its known safety profile from previous PEARL interim analyses and randomised controlled trials, supporting its continued clinical use for migraine prevention.²

“The final analysis of the PEARL real-world study reaffirms the long-term effectiveness and safety profile of fremanezumab in the preventive treatment of chronic and episodic migraine,” said Pinar Kokturk, M.D., Vice President and Head of Medical Affairs Europe at Teva. “These data provide valuable real-world evidence supporting fremanezumab’s sustained clinical benefit, particularly in a population burdened by high disease impact and a need for preventive therapy. With migraine being the second leading cause of disability worldwide,³ the recognition of CGRP-pathway therapies by health authorities is critical for improving patient outcomes.”

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 first 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.

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquires:
TevaIR@Tevapharm.com

References

1. Ashina M. et al, Real-World Effectiveness of Fremanezumab in Migraine Prevention: Final Outcomes of the Pan-European PEARL Study (EPR-039), poster presented at the European Academy of Neurology (EAN) Congress; 21 – 24 June, 2025; Helsinki, Finland.
2. Ashina M et al, Real-World Safety and Tolerability of Fremanezumab in Migraine Prevention: Final Outcomes of the PEARL Study (EPO-063), poster presented at the European Academy of Neurology (EAN) Congress; 21 – 24 June, 2025; Helsinki, Finland.
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 Pain 21, 137 (2020).

FAQ

What were the key findings of Teva's PEARL study for AJOVY (TEVA)?

The PEARL study showed that AJOVY provided sustained migraine prevention over 24 months, with over 66% of episodic migraine patients and 51.6% of chronic migraine patients achieving ≥50% reduction in Monthly Migraine Days.

How many patients participated in Teva's PEARL study for AJOVY?

The study included 1,140 patients, with 87.25% being female, 33.1% having episodic migraine, and 66.9% having chronic migraine.

What was the adherence rate for AJOVY in Teva's PEARL study?

The injection adherence rate remained high at approximately 90% throughout the study, with over 75% of participants completing the full 24-month study duration.

Is AJOVY (fremanezumab) effective for both chronic and episodic migraine?

Yes, the PEARL study demonstrated that AJOVY is effective for both chronic and episodic migraine, showing sustained effectiveness over a two-year period in reducing frequency, duration, and severity of migraine attacks.

What is the safety profile of AJOVY based on the PEARL study results?

The study showed that AJOVY maintained a favorable long-term safety and tolerability profile, consistent with its known safety profile from previous PEARL interim analyses and randomized controlled trials.