Teva’s 3rd interim analysis of PEARL real-world study on AJOVY® (fremanezumab) reveals sustained long-term effectiveness in reducing frequency, duration and severity of attacks in patients with chronic and episodic migraine

Data presented at the European Academy of Neurology Congress 2023

TEL AVIV, Israel–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. today announces further positive data from the pan-European PEARL study investigating the impact of AJOVY^® (fremanezumab) on the prevention of migraine in a real-world setting,¹ due to be completed in 2024.

The data from the 3^rd interim analysis² reveals that almost 60% of patients achieved a ≥50% reduction in monthly migraine days from baseline for migraine prevention, with sustained improvement in disability scores and acute medication use observed over 12 months. Treatment persistence rates were high, with 82.3% of patients remaining on treatment by month 12.

Not only was fremanezumab effective in preventing migraine attacks in patients with chronic and episodic migraine, but it has also shown to be effective in reducing the severity and duration of remaining migraine attacks.

Four abstracts from the third interim analysis of the PEARL study will be presented at the 9^th European Academy of Neurology (EAN) Congress in Budapest, Hungary. The primary analysis is being presented as an oral presentation by Professor Cristina Tassorelli, Department of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy on July 1, 2023.

Commenting on the findings, Professor Tassorelli said: “Preventive treatments are of the utmost importance for reducing the burden of severe migraine, but levels of use of preventive drugs across Europe are still low, resulting in sub-optimal patient care. These interim findings add to our growing evidence with fremanezumab in the real-world, showing how the burden of migraines can be reduced when an eligible patient has access to monoclonal antibodies like fremanezumab.”

Pinar Kokturk, M.D. Vice President & Head of Medical Affairs Europe at Teva, said: “The 3^rd interim analysis of the PEARL study provides valuable insights for clinicians and patients into the effectiveness of fremanezumab (AJOVY^®) in a real-world setting. Real-world data allows us to bridge the gap between scientific evidence and the complexities of real-life scenarios, offering a comprehensive understanding of how treatments truly impact patients’ lives. The PEARL study is particularly relevant to clinicians due to its large patient cohort, coming from 11 countries across Europe”.¹

Editors’ Notes – Summary of PEARL 3^rd interim analysis data set:

PEARL Primary Analysis

Real-world effectiveness & safety of fremanezumab in migraine: 3rd interim analysis of the pan-European PEARL study²

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. 968 patients (87.3% female) out of the 1140 study patients had available data to include in the 3^rd interim analysis. The findings show that 58.5% of the patients had their monthly migraine days reduced by 50% or more at 12 months of treatment. Additionally, sustained reduction in disability scores and acute medication use were observed over 12 months. This interim analysis included a larger patient population over a longer duration than previous interim analyses, creating more robust data supporting the clinical use of fremanezumab.

PEARL Sub-Analyses

Fremanezumab adherence & persistence along with past & concomitant migraine medication use: PEARL 3rd interim analysis³

This sub-analysis examined treatment adherence and persistence, and patient use of acute migraine medications during the study. High treatment persistence rates were seen in patients taking fremanezumab with 82.3% remaining on treatment at Month 12. An alternative calculation method was developed to assess adherence to fremanezumab, and the results indicated that adherence rates remained at ≥90% from injection 1–12 months inclusive. The mean number of days each month that patients used triptans (one of the most frequently prescribed medications for treating moderate to severe attacks) decreased to 7.7 days to 2.8 days over 12 months.

Impact of fremanezumab initiation on migraine severity, and the duration of remaining attacks: 3^rd interim analysis of the PEARL study⁴

The clinical success of migraine preventive treatment is typically measured by a reduction in monthly migraine days (MMD) however, for some patients, the severity and duration rather than the frequency of migraine attacks has a greater impact on their daily lives. Increased duration and severity of migraine has been shown to be associated with increased migraine related disability, psychological comorbidity and decreased quality of life. This sub-analysis looked at the impact of fremanezumab on the severity and duration of remaining migraine attacks. The mean monthly duration of remaining migraine attacks and monthly mean score for peak headache severity of remaining migraine attacks decreased at 12 months after fremanezumab initiation. These data suggest that treatment with fremanezumab can reduce both the duration and severity of remaining migraine attacks, and can consequently lead to improvements in quality of life outcomes.

Real-world effectiveness of switching to fremanezumab from other CGRP pathway targeting mAbs: 3^rd interim analysis of the PEARL study⁵

In 2022, updates to the European Headache Federation (EHF) guidelines for the use of CGRP pathway mAbs in migraine prevention noted that switching from one CGRP pathway mAb to another may be beneficial for patients experiencing adverse events or a lack of efficacy.⁶ In this sub-analysis of PEARL, the effectiveness of fremanezumab in patients who had previously received another medication from the CGRP pathway mAb class was assessed. During the first 6 months of fremanezumab treatment, 32.3% of ‘switch’ patients achieved ≥50% reduction in MMD from baseline. A reduction of ≥30% in MMD is often considered clinically meaningful in CM patients^7,8 and was observed in 60.9% of switch patients with CM included in this analysis. These results are consistent with those observed with fremanezumab in the FINESSE study,⁹ and suggest that switching to fremanezumab may offer a beneficial treatment option in patients for whom other CGRP pathway mAbs have failed due to inadequate response or tolerability reasons.

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.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events. Information can be found at https://www.hpra.ie.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at 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 the development and commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize competition for our innovative medicines, including AUSTEDO^®, AJOVY and COPAXONE^®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section 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.

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1 Ashina, M. et al, PEARL study protocol. Pain management, 11(6), 647–654. (v0.1) – The two year Pan- European Real World (PEARL) prospective, observational study of AJOVY® (fremanezumab).

2 Ashina, M., et al. Real-world effectiveness & safety of fremanezumab in migraine: 3rd interim analysis of the pan-European PEARL study. Presented at European Academy of Neurology (EAN); 1-4 July 2023; Budapest

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3 Tassorelli, C., et al. Fremanezumab Adherence and Persistence Along with Past and Concomitant Migraine Medication Use: PEARL 3rd Interim Analysis. Presented at European Academy of Neurology (EAN); 1-4 July 2023; Budapest EAN-EPO-582

4 Tassorelli, C., et al. Impact of Fremanezumab Initiation on Migraine Severity and Duration of Remaining Attacks: 3rd Interim Analysis of the PEARL Study. Presented at European Academy of Neurology (EAN); 1-4 July 2023; Budapest EAN-EPO-583

5 Ashina, M., et al. Real-World Effectiveness of Fremanezumab with Switching from Other CGRP Pathway Targeting mAbs: PEARL Study 3rd Interim Analysis. Presented at European Academy of Neurology (EAN); 1-4 July 2023; Budapest EAN-EPO-075

6 Sacco S., et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update. J Headache Pain. 2022 Jun 11;23(1):67.

7 Dodick DW., et al. Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example. J Pain. 2015 Feb;16(2):164-75.

8 Tassorelli C., et al. International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832.

9 Lee MJ., et al. New migraine prophylactic drugs: Current evidence and practical suggestions for non-responders to prior therapy. Cephalalgia. 2023 Feb;43(2).

 

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