From Clinical Trial Efficacy to Real-World Effectiveness First AJOVY® ▼ (fremanezumab) Data from European Real World Evidence Program

8 November 2021, Teva Germany (GmbH) presented at the DGN Congress 2021 the first interim analysis results of the FINESSE study aiming to provide real-world evidence of fremanezumab treatment outcomes by evaluating effectiveness in routine clinical practice. 97.6% of patients included in the study had already received preventive migraine therapies in the 10 years prior to study entry, including antidepressants, anticonvulsants, beta-blockers, ca-antagonists, onabotulinumtoxinA as well as other anti-CGRP mAbs.¹

The interim analysis results were shared in a poster presentation at the congress by Prof. Andreas Straube, from Ludwig-Maximilians University Munich, Germany, who is the principal investigator of the study.

The presented FINESSE interim data¹ indicate that real-world response rates are consistent with Phase-III-study results of fremanezumab.^2,3,4 “The results indicate that anti-CGRP mAbs such as fremanezumab also work outside of randomized clinical trials in a migraine patient population who has previously experienced inadequate response to multiple preventive therapies. Real-world evidence can provide vital insight into treatment effects in more naturalistic clinical settings, where many patients have multiple co-morbidities”, said Professor Straube.

The primary endpoint measure was the proportion of patients reaching ≥ 50% reduction in the monthly average number of migraine days evaluated during the 6-month period after the first dose of fremanezumab.

• 48.7% of the patients with 6-month data achieved the primary endpoint, with a higher percentage in EM (53.2%) than CM patients (43.0%). Real-world response rates are thus in line with Phase-III-study results of fremanezumab.
• The mean number of migraine days per month (d/m) decreased from 12.7 (baseline) to 6.2 (month 6).
• From baseline to month 6, the mean MIDAS Score decreased from 74.8 at baseline to 32.8 and the mean HIT-6 Score from 65.9 at baseline to 56.6
• Acute migraine medication use decreased from 9.6 days/month at baseline to 4.4 d/m at month 6.

Danilo Lembo, Vice President Teva Medical Affairs EU commented:

To provide further support in understanding migraine prevention in clinical practice, we have initiated a comprehensive European Real World Evidence program with FINESSE and PEARL studies which are being carried out throughout Europe.

“Today we are excited to see these first interim results from the FINESSE study which are a strong validation of the data previously seen with Teva’s migraine preventive treatment.

“Real-world evidence (RWE) studies provide information that is relevant to patient care and can help clinicians, researchers, regulators and payers to better understand the drugs and their impact on patients outcomes.

“Also real-world evidence is complementary to randomized clinical trial and in recent years it has become increasingly important to improve clinical practice, amend treatment guidelines and support access decisions.”

About the Study

• FINESSE is a 49-month (25-month recruitment and 24-month follow-up) multicenter, two-country (Germany/Austria), prospective observational study.
• Eligible patients are adults (≥ 18 years) diagnosed with EM or CM who have been prescribed fremanezumab according to the Summary of Product Characteristics (SmPC).
• The primary endpoint is the proportion of patients reaching ≥ 50% reduction in the monthly average number of migraine days evaluated during the 6-month period after the first dose of fremanezumab.
• Relevant secondary effectiveness endpoints include changes from baseline in: (1) Monthly average number of migraine days; (2) Disability scores; (3) Days of acute migraine medication use per month.
• Effectiveness data is evaluated using data from patient diaries and patient-reported outcome measures (disability scores).
• Recruitment of the FINESSE study is still ongoing.

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 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 healthcare 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.

Adverse events should be reported. Reporting forms and information can be found at https://www.hpra.ie.

About Teva

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 specialty 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 specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

References:

1. Straube A et al. Effectiveness of Fremanezumab for Preventive Treatment in Migraine: The Non-Interventional FINESSE Study. Poster presented at DGN Congress 2021, November 3-6, 2021
2. Dodick DW et al. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine. A Randomized Clinical Trial. JAMA. 2018;319(19):1999–2008. doi:10.1001/jama.2018.4853
3. Silberstein SD, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 2017;377:2113–22. doi:10.1056/NEJMoa1709038
4. Ferrari MD et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019:394(10203):1030–1040. doi:10.1016/S0140-6736(19)31946-4

Safe Harbour Statement:

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 commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, 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 uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general, our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith, costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; 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 Annual Report on Form 10-K for the year ended December 31, 2020, 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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Contact information

Fiona Cohen, Teva Corporate Communications Europe : +31 6 2008 2545